Podcasts about importers

Artificial intelligence is transforming healthcare, but developing an AI medical device is only part of the challenge. Manufacturers must also navigate certification requirements and maintain safety and performance throughout the entire product lifecycle.In two podcast episodes featuring Sandy Wright and Osman El-Koubani, we explore the journey from certifying LLM-driven medical devices to managing them after CE marking.Certifying LLM-Driven Medical DevicesLarge Language Models such as ChatGPT, Gemini, and Claude introduce new regulatory challenges. Unlike traditional software, these systems raise questions around predictability, validation, traceability, supplier management, and model updates.Topics discussed include:What defines an LLM-driven medical deviceClinical evaluation strategiesDemonstrating clinical benefitUsing commercial AI modelsSupplier controls and external dependenciesSignificant changes and model updatesLife After CE MarkingObtaining CE certification is not the end of the journey.AI medical devices require continuous monitoring once they reach the market.Manufacturers must address:Performance drift in real-world settingsCollection and analysis of real-world dataAI retraining and change managementPredetermined Change Control Plans (PCCPs)Post-Market Surveillance (PMS)Continuous safety and performance evaluationAI Devices Require a Lifecycle ApproachAI systems are dynamic technologies. Success depends not only on achieving certification, but also on maintaining control over performance, updates, and clinical safety throughout the product lifecycle.As regulations continue to evolve, manufacturers must combine robust development practices with proactive post-market monitoring to ensure long-term compliance and patient safety.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkSandy LinkedIn: https://www.linkedin.com/in/wrightsandy/Osman Linkedin: https://www.linkedin.com/in/osman-kan/Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=trueSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

durée : 00:01:52 - Les 80'' - par : Florence Paracuellos - C'est officiel, les Français boivent désormais plus de bière que de vin... et nos voisins britanniques se demandent ce qu'il leur reste à nous enseigner. Vous aimez ce podcast ? Pour écouter tous les épisodes sans limite, rendez-vous sur Radio France

Host: Lalo Solorzano, Andy Shiles Guest(s): Ashley Arnold Published: June 4, 2026 Length: Approximately 33 minutes Presented by: Global Training Center Summary Trade compliance has changed dramatically, and this episode digs into why importers, exporters, executives, and compliance professionals can no longer treat it as a back-office task. Lalo Solorzano and Andy Shiles welcome Ashley Arnold, licensed customs broker, CCS, and founder of JEM Consulting, for a timely conversation on the evolving role of trade professionals in today's regulatory environment. Ashley explains how trade compliance now touches sourcing, finance, IT, logistics, purchasing, customer service, and executive strategy. With shifting tariffs, increased Customs scrutiny, ACE reporting, USMCA claims, duty mitigation opportunities, automation, and documentation challenges all demanding attention, the old “we've always done it this way” mindset is no longer enough. The discussion highlights why companies need stronger internal collaboration, better systems, proactive monitoring, and more visibility into what Customs sees in real time. For executives, this episode is a reminder that compliance teams need resources, support, and a seat at the table. For trade professionals, it is a call to stay informed, ask questions, build relationships across departments, and keep pushing for smarter processes. Main Topic / Discussion This episode focuses on the expanding role of trade compliance professionals and why companies must rethink how they support compliance, logistics, and supply chain teams. Ashley Arnold explains that compliance work is no longer limited to classification, entry review, or post-entry audits. Today's trade professionals are monitoring court cases, tariff updates, government notices, ACE reports, Customs requests, free trade agreement documentation, software workflows, and automation opportunities. The conversation also emphasizes that compliance must be involved earlier in the business process. Purchasing, sourcing, finance, IT, logistics, and leadership all need to work together to prevent problems before shipments are delayed, costs increase, or Customs issues arise. Key Takeaways • Trade compliance now belongs in strategic planning, not just operations. • Importers should have ACE access, run reports, and monitor Customs activity directly. • USMCA, duty drawback, exclusions, tariff engineering, and free trade agreement claims require strong documentation and audit readiness. • Automation and software can reduce manual work, but qualified trade professionals still need to review and validate decisions. • Compliance teams must build relationships with IT, accounting, sourcing, logistics, purchasing, and customer service. • Executives should ask whether their compliance teams have the tools, people, and cooperation they need. • The phrase “we've always done it this way” is a warning sign in today's trade environment. Resources & Mentions • Global Training Center • Lalo Solorzano on LinkedIn • Andy Shiles on LinkedIn • Ashley Arnold on LinkedIn Credits Host: Lalo Solorzano – LinkedIn Andy Shiles – LinkedIn Guest(s): Ashley Arnold – LinkedIn Producer: Lalo Solorzano

Host: Lalo Solorzano, Denise Smalls-Altagracia Published: June 2, 2026 Length: 20:17 Presented by: Global Training Center Summary In this Simply Trade Tips episode, Lalo Solorzano and Denise Smalls-Altagracia break down one of the most important but often misunderstood parts of U.S. import compliance: Partner Government Agencies, or PGAs. While many importers focus mainly on CBP, duties, tariffs, and broker filings, Denise explains why customs clearance is often much bigger than paperwork and duty payments. PGAs regulate the products themselves, covering areas such as public health, safety, agriculture, environmental standards, transportation, and security. That means an entry may look correct from a customs perspective but still be delayed, detained, or refused if agency-specific requirements are missed. Denise also highlights common agencies importers may encounter, including FDA, USDA, APHIS, EPA, and CPSC, and explains why documentation, product classification, and early planning are essential. This episode matters because PGA compliance directly affects speed, predictability, cost control, and supply chain reliability. Importers who understand agency requirements before shipments move are far better positioned to avoid costly surprises and keep trade moving. Main Topic / Discussion This episode focuses on Partner Government Agencies and their role in the import process. Lalo and Denise explain that CBP may serve as the primary border authority, but PGAs are the subject matter experts that determine whether certain products meet U.S. requirements and can legally enter commerce. The discussion covers what PGAs are, why they matter, which agencies importers commonly encounter, what documentation may be required, and how PGA compliance should be treated as a business function rather than a last-minute customs task. Key Takeaways • PGAs are federal agencies that work with CBP to regulate specific imported products. • Import compliance is not only about duties, tariffs, and customs paperwork. • Agencies such as FDA, USDA, APHIS, EPA, and CPSC may require additional documentation or review depending on the product. • Missing or inaccurate PGA information can lead to delays, detention, refusal, penalties, or supply chain disruption. • Strong PGA compliance improves shipment speed, predictability, cost control, and business reputation. • Companies should identify agency requirements before purchase orders are issued or goods are shipped. Resources & Mentions • Global Training Center • Lalo Solorzano on LinkedIn • Denise Smalls-Altagracia on LinkedIn • Import Training Courses from Global Training Center Credits Host: Lalo Solorzano – LinkedIn Denise Smalls-Altagracia – LinkedIn Producer: Lalo Solorzano

The FDA's new Quality Management System Regulation (QMSR) officially became effective on February 2nd, 2026, replacing the legacy Quality System Regulation (QSR) framework that had been in place for nearly 30 years.Three months later, the reality is becoming clear for many manufacturers:QMSR is far more than a simple regulatory update.It represents a complete transformation in how the FDA expects companies to manage quality, risk, design controls, manufacturing, supplier oversight, and post-market surveillance.From Siloed Quality to Lifecycle ThinkingUnder the old QSR framework, companies often treated quality activities separately:Design controlsCAPAManufacturingSupplier managementPost-market surveillanceQMSR changes this mindset entirely.FDA now expects manufacturers to demonstrate integrated, risk-based quality management across the entire product lifecycle.This means:Design changes must connect to manufacturing validationSupplier issues must feed into risk managementPost-market surveillance must proactively identify trendsManagement reviews must show real decision-makingWhy Many Companies Were Not ReadyA major misconception across the industry was believing that ISO 13485 certification automatically meant QMSR readiness.But manufacturers are now discovering major gaps:Incomplete Design History Files (DHF)Weak risk integrationPoor documentation traceabilityReactive PMS systemsLimited management review evidenceFDA inspections are already reflecting these expectations.Inspectors are requesting:Internal audit reportsSupplier audit documentationManagement review recordsRisk-based decision evidenceThis level of transparency is new for many organizations.Real-World Challenges Manufacturers Are FacingOne of the biggest pain points is DHF restructuring.Companies with years of design changes are now being forced to reconstruct the logic behind historical decisions and organize fragmented information into a coherent, risk-based structure.Another major shift is Post-Market Surveillance.QMSR pushes manufacturers from reactive complaint handling toward proactive monitoring of known high-risk failure modes using trend analysis, registries, and real-world data.Management review processes are also under greater scrutiny.FDA now expects leadership teams to demonstrate how quality data drives actual strategic decisions.Best Practices for QMSR TransitionManufacturers preparing for QMSR should focus on:1. Cross-functional collaborationBreak down silos between QA, RA, Manufacturing, Design, and Supply Chain.2. Documentation mappingIdentify where critical design logic and risk decisions currently exist.3. Continuous risk managementImplement ongoing cross-functional risk review meetings.4. Stronger internal auditsMove beyond checklist auditing toward analytical risk-focused auditing.5. Meaningful management reviewsUse management review meetings to demonstrate active leadership involvement in quality decisions.Final ThoughtsQMSR is fundamentally changing the FDA's expectations.Companies that adapt early will build stronger systems, improve product quality, and reduce regulatory risk.Companies that delay may face:FDA 483 observationsWarning LettersProduct launch delaysIncreased remediation costsThe transition to QMSR is not simply a compliance project.It is a complete redesign of how medical device companies manage quality.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkMathangi Srinivasan linkedin: https://www.linkedin.com/in/mathangiks/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

A medical device's intended use is not just a regulatory formality — it is the foundation of the entire product strategy.In this podcast episode, Monir El Azzouzi speaks with Karandeep Badwal about how intended use influences classification, clinical evaluation, risk management, labeling, and ultimately market access.The discussion explores why many companies underestimate the importance of intended use and how poorly written statements can create major downstream regulatory problems. From Software as a Medical Device (SaMD) to AI-driven products, the episode highlights real-world examples where unclear intended use created challenges during certification and compliance activities.The episode also provides practical guidance for manufacturers on:Defining a robust intended use statementAligning intended use with clinical evidence and risk managementAvoiding “labeling tricks” that may trigger regulatory scrutinyBuilding internal collaboration between regulatory, clinical, and product teamsThis is an essential discussion for MedTech startups, QA/RA professionals, and manufacturers navigating MDR, IVDR, FDA, or global regulatory pathways.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Linkkarandeepbadwal linkedin: https://www.linkedin.com/in/karandeepbadwal/qra-medical linkedin: https://www.linkedin.com/company/qra-medical/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Host: Lalo Solorzano and Trudy Wilson Published: May 19, 2026 Length: 13:24 Presented by: Global Training Center Summary In this episode of Simply Trade, Lalo Solorzano and Trudy Wilson return for another Trudy's Trade Tips segment, shifting the conversation from Incoterms to USMCA and free trade agreements. The big message: you do not have to participate in a free trade agreement just because one is available. Trudy explains why companies should pause before making USMCA or other FTA claims, especially if they do not have the proper documentation, qualification process, or internal controls in place. While free trade agreements can offer legitimate duty savings, they also come with responsibility. If your company claims preferential treatment, Customs can verify that claim, and you need to be ready to prove the goods qualify. The episode also highlights why importers are not required to use a certificate just because they receive one, and why other duty-free provisions, such as Chapter 98, may sometimes be worth reviewing. Trudy closes with a key warning about USMCA preference criterion A: if you see it, challenge it. Main Topic / Discussion This episode focuses on whether companies should participate in a free trade agreement, with special attention on USMCA. Trudy explains that FTAs can be valuable tools for reducing duty, but they should not be used casually or automatically. A major point of discussion is the importance of supporting documentation. Companies that make USMCA claims must be able to prove that their products qualify under the agreement. If they cannot, they may be exposing themselves, and their customers, to verification risk. Trudy also explains that importers have a choice. Even if a supplier provides a free trade agreement certificate, the importer does not have to use it. In some cases, another duty-free provision may be more appropriate, but those options also require documentation and proper reporting. The conversation also introduces preference criteria, especially criterion A. Trudy warns that criterion A is often misunderstood and should only be used when every part, component, ingredient, or input can be traced back to the U.S., Mexico, or Canada. Key Takeaways • You do not have to participate in a free trade agreement simply because one is available. • USMCA and other FTAs can provide legitimate duty savings, but only when the goods truly qualify. • Companies should pause FTA claims if they do not have proper documentation or internal procedures in place. • Making an FTA claim can increase the likelihood of review or verification by Customs. • Importers do not have to use a supplier's certificate if they are not comfortable with the qualification. • Other duty-free options, such as Chapter 98, may be available but still require supporting documentation. • Under USMCA, preference criterion A should be challenged unless the company can prove every input is originating. Resources & Mentions • Global Training Center • TruTrade Solutions Credits Host: Lalo Solorzano – LinkedIn Trudy Wilson – LinkedIn Producer: Lalo Solorzano

Si La France Insoumise tourne aujourd'hui son regard vers les États-Unis, c'est parce que New York est devenue le laboratoire à ciel ouvert de son propre programme économique. En prenant pour modèle Zohran Mamdani, le jeune maire issu de l'aile gauche des démocrates, le mouvement de Jean-Luc Mélenchon cherche à prouver qu'une rupture radicale avec le néolibéralisme est non seulement possible, mais surtout efficace.Le principal argument de LFI repose sur un tour de force budgétaire majeur, récemment mis en lumière par Le Figaro. À son arrivée à la mairie, Mamdani a hérité d'une situation financière critique, avec un déficit abyssal de 12 milliards de dollars. Là où la doctrine économique classique aurait exigé une cure d'austérité et des coupes sombres dans les services publics, l'édile new-yorkais a fait le choix inverse. Il a appliqué la recette dont rêve LFI pour la France : équilibrer les comptes par le haut, en augmentant la fiscalité sur les hauts revenus et les grandes entreprises, tout en menant un bras de fer politique avec l'État de New York pour récupérer des fonds.Pour les insoumis, cette stratégie est une aubaine idéologique. Elle valide leur théorie de la demande en démontrant que la redistribution stimule l'économie. En finançant des mesures concrètes de pouvoir d'achat — comme le gel des loyers, les crèches publiques ou la gratuité des bus —, Mamdani a stabilisé le tissu social sans faire fuir les capitaux. Même certains géants de Wall Street ont fini par accepter ce deal, préférant la paix sociale à la baisse aveugle des impôts.Enfin, c'est la méthode Mamdani qui fascine LFI : une stratégie de confrontation politique habile, capable de plier les modérés à sa volonté par le simple rapport de force. En résumé, pour vos auditeurs, Zohran Mamdani est le "crash-test" réussi du programme de La France Insoumise. Il incarne la preuve vivante qu'un budget de 125 milliards de dollars peut être redressé sans sacrifier les classes populaires, balayant ainsi le spectre de la faillite souvent agité par les opposants à la gauche de rupture. Hébergé par Acast. Visitez acast.com/privacy pour plus d'informations.

In the latest episode of Five Questions, Five Answers, host Birgit Matthiesen is joined by ArentFox Schiff colleagues Jackson David Toof and Mario A. Torrico for a conversation on the False Claims Act (FCA), its origins, and its continued importance as a tool to combat fraud against the federal government. The discussion examines how US Customs and Border Protection (CBP) and the US Department of Justice (DOJ) are increasingly using the FCA to pursue customs fraud and trade violations, the significant business and reputational risks companies face, and the compliance missteps that commonly lead to enforcement actions. It also highlights the importance of proactive compliance strategies for managing FCA exposure. Takeaways - The FCA is a long-standing and powerful enforcement tool. - FCA enforcement by CBP and the DOJ is increasing sharply. - FCA violations pose serious financial and reputational risks for importers. - Compliance exposure most often arises from classification, valuation, and country‑of‑origin errors. - Proactive compliance programs offer both risk reduction and competitive advantage.

Unique Device Identification (UDI) has become a central element of medical device compliance worldwide.From EUDAMED in Europe to FDA databases in the United States, regulators increasingly rely on accurate UDI data to improve traceability and patient safety.But many manufacturers underestimate one important reality:

Six months sounds generous. For container freight from China to South Africa via the Cape, the effective PVoC preparation window is fourteen weeks. Here is why the loading date matters more than the arrival date, and what importers should be doing now. LinkDaddy LLC City: Clearwater Address: 509 N Prescott Avenue Website: https://linkdaddy.com Phone: +1-727-350-8520 Email: tony@linkdaddy.com

The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry.Now, Europe is introducing an additional layer: Master UDI-DI — adding both structure and complexity to the system.Understanding the UDI StructureTo fully understand Master UDI-DI, it's important to distinguish between the different levels:• UDI-DI → Identifies a specific device• Basic UDI-DI → Groups devices with the same intended purpose and characteristics• Master UDI-DI → Applies to highly individualized devices with specific design parametersThis new layer aims to better manage products with high variability.Why Master UDI-DI Was IntroducedFor certain devices — such as spectacle frames, lenses, and other customizable products — the number of variations can become overwhelming.Master UDI-DI helps:• Reduce the number of identifiers required• Improve traceability• Simplify product grouping• Enhance recall efficiencyKey BenefitsDespite its complexity, Master UDI-DI brings several advantages:✔ Better organization of device data✔ Improved market surveillance✔ Faster identification during recalls✔ Stronger protection against counterfeit productsChallenges for ManufacturersHowever, the implementation is not without challenges:• Increased data requirements• Risk of incorrect UDI assignment• Need for cross-functional coordination• Integration with EUDAMEDAs highlighted in the discussion, errors in UDI can be costly — including recalls and data inconsistencies.Timeline and UrgencyWhile the labeling deadline is set for November 2028, manufacturers should not wait.EUDAMED requirements are already active, and preparation takes time.

All-time highs – SP500 up 9% MTD – NAS100 even more Balanced risk – up or down from here is evenly matched All tech right now (Example Monday Equal Weighted up 0.33%, SP500 down 0.35%) Worried about No More Mr. Nice Guy The new “Blockchain” , “SPAC”, “MEME” that is pushing stocks PLUS we are now on Spotify and Amazon Music/Podcasts! Click HERE for Show Notes and Links DHUnplugged is now streaming live - with listener chat. Click on link on the right sidebar. Love the Show? Then how about a Donation? Follow John C. Dvorak on Twitter Follow Andrew Horowitz on Twitter Warm-Up - HUGE MOVES - All from Tweets - Earnings seasons - banks did goooood -- Earnings season - carrot ahead of next week when the tech giants report (lots of bulls on this) - A belated 420 day to all you stoners out there! Grab a gummy, come back in about 45 minutes and listen - show will be much better... - Tariff refunds now available Markets - All-time highs - SP500 up 9% MTD - NAS100 even more - Balanced risk - up or down from here is evenly matched -- All tech right now (One day Equal Weighted up 0.33%, SP500 down 0.35%,) - Equal weight up 4.5% MTD, S&P up 9% - Worried about No More Mr. Nice Guy ? - Seems like Trump is bored with the Iran thing... - The new "Blockchain" , "SPAC", "MEME" that is pushing stocks Announcing the Winner of the Closest to the Pin for NetGear... Open /Closed - Straits of Hormuz closed again, and again - The brief opening allowed for a cruise ship to sneak through last week. - Celestyal Discovery, a 1,360-guest vessel operated by Greece-based Celestyal Cruises, departed Port Rashid in Dubai, U.A.E., on April 17 at 11:36 a.m. local time, becoming the first cruise ship known to exit the strait since the crisis began earlier this year. - No passengers aboard - aside from Captain and Crew. - - That must have been a pretty scary passing.... OIL - Oil hovering in the $80-$90 range for a while, now topping $100 - WTI and Brent flipped back to the normal relationship - UAE leaving OPEC - (accounts for 12% of OPEC and 4% of global oil) ---- They need more flexibility and there seems to be a rift  with Saudi Arabia and others as they have not been protected -- China! China to begin exporting jet fuel, diesel and gasoline - DOES THIS MEAN PRICED IN YUAN? Economics - Retail sales up more than expected. - Some is due to the high cost of gas - but stripping out gas prices - still beat expectations - How do we square this with the UMich at all-time lows? Consumer Confidence Retail Sales YoY Chips - MRVL Shares jumped more than 7% after a report by The Information said the company is in talks with Google to build two new AI chips. - AVGO (Broadcom) dipped as they had a deal announced prior and this seems to have watered down some of the importance. - Fast forward a few days and then we see a story about OpenAi missing user and revenue projections. Commentary about concern that if they do not meet their numbers, may not have enough money to fund all the build-outs they promised. (Lots of names dropping on this concern) Tim Apple - Apple announces that Tim Cook will become executive chairman of Apple's board of directors and John Ternus, senior vice president of Hardware Engineering, will become Apple's next chief executive officer effective on September 1, 2026. - Ternus joined Apple's product design team in 2001 and became a vice president of Hardware Engineering in 2013. He joined the executive team in 2021 as senior vice president of Hardware Engineering. Throughout his tenure at Apple, Ternus has overseen hardware engineering work on a variety of groundbreaking products across every category. He was instrumental in the introduction of multiple new product lines, including iPad® and AirPods, as well as many generations of products across iPhone®, Mac®, and Apple Watch. - Ternus's work on Mac has helped the category become more powerful and more popular globally than at any time in its 40-year history. Prior to Apple, Ternus worked as a mechanical engineer at Virtual Research Systems. He holds a bachelor's degree in Mechanical Engineering from the University of Pennsylvania. Mo Money - Vendor Financing - Anthropic to secure up to 5 gigawatts (GW) of current and future generations of Amazon's Trainium chips to train and power their advanced AI models. - Anthropic's Claude Platform available on AWS, providing their full AI developer experience in one place. - Amazon to invest $5 bln in Anthropic today and up to an additional $20 bln in the future. Operation Vaccu Suck - AST SpaceMobile — Shares fell 15% after a satellite launched  was placed into the wrong orbit. - The company said in a release it expects the cost of the satellite to be recovered by an insurance policy, and it still plans to conduct orbital launches once every month to two months in 2026. - DH Space Cleanup - this is going to be huge. Like the Spaceballs Mega Maid Scene - goes from suck to blow. Mega maid cleaning up space trash - Operation Vaccu Suck Fed Chair Nominee - Fed Chair nominee Kevin Warsh told Senate hearing that Fed must stay independent and "stay in its lane" - Opening statement (Senate) : "I do not believe the operational independence of monetary policy is particularly threatened when elected officials—presidents, senators, or members of the House—state their views on interest rates. Central bankers must be strong enough to listen to a diversity of views from all corners. - But the actual confirmation may still be stuck until the lawsuit against Powell is dropped (Which it seems is in process) Drugs man... - Compass Pathways — The biotechnology company surged nearly 25% after President Donald Trump signed an executive order that directs his administration to speed up reviews of psychedelic drugs. - Compass is conducting studies of psychedelics to create drugs for treatment-resistant depression and PTSD. HOW? - A refund system for businesses that paid tariffs which the U.S. Supreme Court ruled President Donald Trump imposed without the constitutional authority to do so is scheduled to launch Monday. - Importers and their brokers will be able to begin claiming refunds through an online portal beginning at 8 a.m., according to U.S. Customs and Border Protection, the agency administering the system. - It's the first step in a complicated process that also might eventually lead to refunds for consumers who were billed for some or all of the tariffs on products shipped to them from outside the United States. SUBS Emerging - Sandwich chain Jersey Mike's has confidentially filed for an IPO. - - Blackstone bought a majority stake in the sandwich chain in 2024 in a deal that valued the company at roughly $8 billion. - - - With more than 3,000 locations nationwide, Jersey Mike's is the second-largest hoagie sandwich chain in the U.S. -- Did some research - typical franchisee makes about $100-$200k per store. ----- Initial cost to get store going ~ $700k (3-7 year make-good on initial investment plus risks) NEW Stock MOVER - SPACS were HOT - now by all accounts one of the worst performance groups EVER - AI Pivot - - - Not sure this has legs like some of the ones in the past... - Myseum shares more than doubled after the social media firm became the latest company to refocus efforts on artificial intelligence. -----Shares of Myseum, which has been renamed Myseum.AI, will still trade under the MYSE ticker - The New Jersey-based company announced Wednesday that it would change its name to Myseum.AI amid a concentration on integrating AI into its platforms like Picture Party and DatChat. Myseum will use AI agents to manage personal media in a way that adapts to users' preferences while also maintaining privacy, the company said. - Allbirds' shares during the previous session after the struggling shoemaker announced a pivot to AI (Went from $3 to $24 and now $11) Crypto News - Charles Schwab is rolling out crypto trading, allowing clients to buy bitcoin and ether in the coming weeks. - The move places the brokerage in direct competition with Robinhood and Coinbase, both of which tend to serve younger clients and offer commission-free trading on stocks (but still carry a fee on crypto). - Schwab is the latest example of increasing crypto acceptance by traditional financial firms that previously were waiting on the sidelines to launch crypto offerings. (Only Ether and Bitcoin) -- Stock was down on this news an some earnings hangover (8% from recent high) - Robinhood and Coinbase had some selling on the news too.... OpenAi - Nastyness - Sam Altman is seeking the dismissal of punitive damages claims in his sister's civil lawsuit accusing the OpenAI co-founder and chief executive of repeated sexual abuse more than two decades ago, an accusation he denies. - Annie Altman accused her brother of sexually abusing and raping her between 1997 and 2006 at the family home in suburban Clayton, Missouri, starting when she was three and he was 12. She said the "last acts of sexual abuse and rape" occurred when Sam Altman was an adult. He is now 40. - Sam Altman is countersuing his sister for defamation over her posts, including a video that said "an almost tech billionaire" molested her. (He is seeking $1) Other Strange - FBI Director Kash Patel filed a defamation lawsuit against the Atlantic and its reporter Sarah Fitzpatrick following the publication of an article on Friday alleging the director had a drinking problem that could pose a threat to national security. - The magazine's story, initially titled “Kash Patel's Erratic Behavior Could Cost Him His Job," cited more than two dozen anonymous sources expressing concern about Patel's “conspicuous inebriation and unexplained absences” that “alarmed officials at the FBI and the Department of Justice.” - The lawsuit, filed in U.S. District Court for the District of Columbia, seeks $250 million in damages. Netflix News - Netflix beat Wall Street expectations for first-quarter revenue and reported a big jump in earnings per share thanks in part to a termination fee related to its proposed Warner Bros. Discovery deal. - The company said it expects second-quarter revenue to increase 13% and reiterated its earlier warning that content spending would be weighted in the first half of the year due to the timing of title launches. - The company announced Reed Hastings, Netflix's co-founder and current chairman, would exit the board in June when his term expires. - Netflix reiterated that it's on track to reach $3 billion in advertising revenue in 2026, which would mark a doubling year over year, as that newer revenue line shows growth. ----Shares fell 9% after the announcement QVC - QVC Group Inc. has filed for bankruptcy protection in an effort to shed $5 billion in debt, as the company struggles with declining network viewership and stiff competition for its e-commerce operation. - QVC's business model, which relies on live sales sessions and call-in ordering, gave customers a sense of a personal relationship with their favorite peddlers, but the company's best year ever was in 2020, during the Covid-19 pandemic, and its revenue has dropped by more than a third since then. - The rise of short-form video platforms like TikTok, which has seen success with live shopping and has brought in more than $15 billion in US revenue in 2025, poses a significant challenge to QVC as it tries to restructure its debt and evolve its business model. - There will still be QVC for a while - really just a debt restructure - but eventually they are toast Spirit - 9 Lives? - Spirit Aviation Holdings Inc. has floated offering the US government an equity stake in the discount carrier to help stave off its potential liquidation, according to people familiar with the matter. - The Air Current first reported that Spirit is seeking a bailout from the US government. - Any proposed bailout is likely to get pushback from competitors that are also struggling with a spike in jet fuel prices during the conflict in the Middle East, some of the people said. Transportation Secretary Sean Duffy plans to meet with low-cost airline chief executives this week to discuss their challenges, the people said. Just IN - Jetblue CEO told employees it isn't considering filing for bankruptcy protection this year. - Geraghty's comments come amid higher fuel costs and speculation sparked by the New York-based carrier's founder that the airline could go bust. - The airline has sufficient liquidity and access to additional capital, Geraghty said in an internal memo reviewed by Bloomberg. That includes a recently secured $500 million loan backed by aircraft, with an option to raise another $250 million. Robot 1/2 Marathon - A humanoid robot completed a half-marathon in 50 minutes and 26 seconds, about seven minutes faster than the men's world record. - The second annual robot half marathon showed rapid advances in artificial intelligence, with 40% of the robots running autonomously and demonstrating improvement in handling generalized environments. - The race, which featured over 100 teams and 300 robots, showcased China's industrial policy priorities, including progress in artificial intelligence and robotics to mitigate the economic risks of an aging population. - About 40% of the robots this year rant autonomously Crazy Short Squeeze AVIS Earnings on the way... Microsoft EPS: ~$4.00–$4.05 (+15–17% YoY) Revenue: ~$81–82 billion (+15–16% YoY) Focus: Azure growth, AI monetization, and whether heavy AI spending is translating into margins. Alphabet (Google) EPS: ~$2.60–$2.70 (~5% YoY decline, due to higher depreciation) Revenue: ~$106–107 billion (+18–20% YoY) Focus: Strong Cloud growth and proof that AI investment is turning into sustainable revenue. Meta Platforms EPS: ~$6.60–$6.70 (+20%+ YoY) Revenue: ~$55–56 billion (+18–22% YoY) Focus: AI?driven advertising performance, core margins, and cost discipline outside Reality Labs. Amazon EPS: ~$1.60–$1.65 (+10–12% YoY) Revenue: ~$177–180 billion (+13–14% YoY) Focus: AWS growth, advertising margins, and clarity around large AI capital spending plans. Apple EPS: ~$1.90–$2.00 (+15–16% YoY) Revenue: ~$90–95 billion (mid?teens YoY growth) Focus: Services growth, iPhone demand stability, and capital return priorities.       Love the Show? Then how about a Donation? THE WINNER OF THE CLOSEST TO THE PIN for NETGEAR Winners will be getting great stuff like the new "OFFICIAL" DHUnplugged Shirt!     FED AND CRYPTO LIMERICKS   See this week's stock picks HERE Follow John C. 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CMPC moves pulp, lumber, plywood, and industrial and consumer packaging from 16 manufacturing sites across South America into North America. Roughly 10,000 TEUs and 300,000 tons of breakbulk annually, touching every Incoterm. Charlie sat down to break down what it actually feels like to run that supply chain through live tariff uncertainty, legacy system inertia, and a Manifest conference floor full of vendors asking for 25 minutes to understand how he procures freight.This conversation was originally recorded on March 11th 2026Connect with Charlie and CMPCCharlie's LinkedInCMPC WebsiteCMPC LinkedInWatch this episode on YouTubeOther episodes mentioned: Charlie's visibility panel at Manifest, which Blythe moderatedEiL's Shipper POV series Happy Robot Series B Raise and their founder Pablo Falafox on EiL -----------------------------------------THANK YOU TO OUR SPONSORS!SPI Logistics has been a Day 1 supporter of this podcast which is why we're proud to promote them in every episode. During that time, we've gotten to know the team and their agents to confidently say they are the best home for freight agents in North America for 40 years and counting. Listen to past episodes to hear why.CargoRex is the search engine for the logistics industry—connecting LSPs with the right tools, services, events, and creators to explore, discover, and evolve.Digital Dispatch maximizes and manages your #1 sales tool with a website that establishes trust and builds rock-solid relationships with your leads and customers. 

Host: Cindy Allen Published: April 24, 2026 Length: ~15 minutes Presented by: Global Training Center Summary In this week's episode of Simply Trade: Cindy's Version, Cindy Allen covers a relatively quiet week in global trade—highlighted by one major development: the successful launch of CBP's CAPE system for IEEPA duty refunds. After months of uncertainty, CAPE is now live—and early feedback from the trade community has been overwhelmingly positive. Importers are already seeing duties removed at the entry level and refund amounts becoming visible, marking a significant milestone in the post-IEEPA landscape. Cindy also touches on ongoing geopolitical risks in the Strait of Hormuz, new developments in Section 232 and 301 actions, and important updates impacting the automotive and pharmaceutical sectors. Inspired by Taylor Swift's King of My Heart, Cindy reflects on whether CAPE might finally be the solution the trade community has been waiting for. This Week in Trade • Continued disruption risks in the Strait of Hormuz, impacting global shipping and energy markets • Accelerated movement on Section 232 and 301 investigations • New tariff relief for steel and aluminum imports from Canada and Mexico used in U.S. automotive production • Ongoing developments in pharmaceutical tariffs, including compliance challenges for importers • Industry feedback submitted on electronic export manifest requirements for ocean shipments CAPE Launch: A Strong Start CBP officially launched CAPE on April 20, and early results are promising: • System launched on time and without major disruption • Filing requires only entry numbers • Importers are already seeing IEEPA duties removed at the line level • Refund amounts are becoming visible and trackable While some minor issues have surfaced—particularly around capped duty scenarios and prior filing instructions—the overall rollout has been widely viewed as a success. What This Means for Trade • CAPE is delivering on expectations—at least in its initial phase • Importers and brokers can begin actively recovering duties • Some entries may still require post-summary corrections before filing • The system's simplicity is enabling broader participation across the trade community Cindy notes that while not perfect, this is one of the most effective system rollouts seen in recent trade operations. Key Takeaways • CAPE is live—and working • Early feedback suggests a smooth and effective rollout • Trade professionals should begin evaluating filing strategies • Broader trade enforcement activity continues to accelerate Resources & Mentions • Global Training Center • Trade Force Multiplier Credits Host: • Cindy Allen – LinkedIn • Trade Force Multiplier Producer: • Lalo Solorzano – LinkedIn Subscribe & Follow New episodes every Friday. Presented by Global Training Center • Simply Trade Podcast on LinkedIn • Global Training Center on LinkedIn • YouTube • Spotify • Apple Podcasts • Trade Geeks Community

Host: Annik Sobing Guests: Federico “Kiko” Zuniga, Kim Campbell & Carlos Martinez Published: November 2025 Length: ~12 minutes Presented by: Global Training Center One Region, One Voice: Strengthening North American Trade Collaboration In this special Simply Trade Roundup episode recorded live at the NCBFAA conference in San Antonio, host Annik Sobing sits down with leaders from the North American Customs Brokers Alliance (NACBA): Federico “Kiko” Zuniga (Chair), Kim Campbell (Treasurer, Canada), and Carlos Martinez (Co-Chair, Mexico). Together, they discuss the importance of collaboration between customs brokers across the United States, Canada, and Mexico — and how a unified industry voice helps shape more efficient and effective border processes. The conversation highlights NACBA's role in addressing trade barriers, educating the industry, and working directly with all three governments to improve cross-border trade. From the ongoing USMCA review to evolving customs regulations and real-world operational challenges, this episode underscores why North America must continue working together to remain a strong and competitive trade region. What You'll Learn in This Episode What NACBA is and how it brings together customs brokers from the U.S., Canada, and Mexico. Why collaboration across North America is critical for seamless trade flows. How NACBA identifies trade barriers and works with governments to resolve them. The current challenges surrounding the USMCA review process. Key regulatory and operational challenges in Canada (CARM) and Mexico (customs reform). How education and industry resources help importers better understand cross-border trade. Key Takeaways A unified voice across North America is more powerful than individual country advocacy. Trade in the region goes beyond economics — it also impacts security and long-term stability. The USMCA review process is a critical moment that will shape the future of regional trade. Importers often underestimate compliance requirements, especially under USMCA qualification rules. Strong collaboration between brokers and governments leads to more practical and effective trade solutions. Resources & Mentions North American Customs Brokers Alliance (via NCBFAA resources) NCBFAA — https://www.ncbfaa.org/?utm_source=SimplyTradePodcast CAAAREM — https://www.caaarem.mx/?utm_source=SimplyTradePodcast USMCA — https://ustr.gov/trade-agreements/free-trade-agreements/united-states-mexico-canada-agreement?utm_source=SimplyTradePodcast Global Training Center — https://www.globaltrainingcenter.com/?utm_source=SimplyTradePodcast Credits Host: Annik Sobing — https://www.linkedin.com/in/annik-sobing-mba-b226251a2/ Guests: Federico “Kiko” Zuniga — https://www.linkedin.com/in/kiko-zuniga-2570086/ Kim Campbell — https://www.linkedin.com/in/kim-campbell-ca/ Carlos Martinez — (CAAAREM, Mexico) Producer: Lalo Solorzano — https://www.linkedin.com/in/lalosolorzano/ Subscribe & Follow New Roundup episodes every week. Presented by: Global Training Center — https://www.globaltrainingcenter.com/?utm_source=SimplyTradePodcast Connect with us: Simply Trade Podcast on LinkedIn — https://www.linkedin.com/showcase/82507159/?utm_source=SimplyTradePodcast Global Training Center on LinkedIn — https://www.linkedin.com/company/global-training-center/?utm_source=SimplyTradePodcast YouTube — https://www.youtube.com/@SimplyTradePod?utm_source=SimplyTradePodcast Spotify — https://open.spotify.com/show/09m199JO6fuNumbcrHTkGq?utm_source=SimplyTradePodcast Apple Podcasts — https://podcasts.apple.com/us/podcast/simply-trade/id1640329690?utm_source=SimplyTradePodcast Trade Geeks Community — https://www.globaltrainingcenter.com/portal/?utm_source=SimplyTradePodcast Don't forget to rate, review, and share with your fellow trade geeks! Want to be on the show or have topic suggestions? SimplyTrade@GlobalTrainingCenter.com or DM @SimplyTradePod on Twitter/X

A few months ago, the oil market looked pretty serene. But the US-Iran war has upended global supplies and pushed energy security to the top of the policy agenda. Importers have realised they need to diversify their energy sources. What role will renewables have to play? And would a shift towards green energy just mean trading one bottleneck for another? Soumaya Keynes speaks to Daniel Yergin, vice-chair of S&P Global and author of the Pulitzer Prize-winning book ‘The Prize: The Epic Quest for Oil, Money, and Power'. Subscribe to Soumaya's show on Apple, Spotify, Pocket Casts or wherever you listen.Further reading: How to survive an energy crunchWill the Iran war derail the energy transition?Middle East war strengthens case for renewables, say clean energy expertsPresented by Soumaya Keynes. Produced by Mischa Frankl-Duval. The senior producer was Michela Tindera. Original music by Breen Turner. Sound design by Samantha Giovinco. The FT head of audio is Cheryl Brumley.Join FT journalists and a special guest on Wednesday 20 May at 1200 GMT for a subscriber webinar on The Dollar under Trump: markets, monetary policy and the next Fed chair. Register at ft.com/trump-dollar and send us your questionsRead a transcript of this episode on FT.com Hosted on Acast. See acast.com/privacy for more information.

Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is not the end of the journey — it is only the beginning.In this episode, Osman El-Koubani shares insights into the post-market realities of AI as a Medical Device (SaMD) and what manufacturers must do to remain compliant over time.CE Certification Is Not the Finish LineMany companies assume that once their device is certified, the main regulatory burden is over.In reality, Post-Market Surveillance (PMS) becomes critical — especially for AI systems that can evolve or degrade in real-world conditions.Relaxing after certification can lead to:• Loss of control over performance• Undetected risks• Regulatory non-complianceAI in the Real World: Performance DriftAI models often behave differently once exposed to real-world data. This phenomenon, known as performance drift, can reduce accuracy and reliability over time.Manufacturers must implement continuous monitoring strategies, including:• Real-world data (RWD) collection• Performance tracking• Feedback loops for improvementUpdating AI Devices: What Is Allowed?Updating AI systems introduces regulatory complexity.Key questions include:• What qualifies as a significant change?• Does retraining require re-certification?• How should updates be documented and justified?Manufacturers often struggle with these decisions, leading to compliance risks.PCCP: Enabling Controlled EvolutionThe concept of a Predetermined Change Control Plan (PCCP) allows manufacturers to define in advance how an AI system can evolve.While this concept is gaining traction globally, its implementation in Europe is still evolving and requires careful regulatory consideration.Building a Mature AI PMS SystemA robust post-market system for AI devices should include:• Continuous performance monitoring• Risk management integration• Clear documentation of updates• Strong governance of data and modelsWho is Osman El-KoubaniDr Osman El-Koubani is a doctor and clinical researcher. With nearly a decade of experience at the intersection of healthcare, digital innovation, and AI, he has developed and implemented NHS digital solutions and advised multiple software and AI medical device startups. At Scarlet, Osman works as a Clinical Engineer and AI/ML expert, leading clinical evaluation, risk management, and usability for AI-driven medical devices, while also helping SaMD and AIaMD manufacturers navigate certification and maintain compliance through transparent, practical, and safety-focused regulatory processes.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkScarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=trueSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

This episode reviews the key definitions for pharmaceutical articles, patented pharmaceuticals, generic pharmaceuticals, and orphan drugs as provided in Annex I to the proclamation. Importers should begin to review their imports according to the tariff code listing and definitions in Annex I.  

Host: Cindy Allen Published: April 17, 2026 Length: ~15 minutes Presented by: Global Training Center Summary In this week's episode of Simply Trade: Cindy's Version, Cindy Allen walks through a pivotal moment for the trade community as CBP prepares to officially launch the CAPE process for IEEPA duty refunds. After weeks of uncertainty, the process is now defined—but key decisions still fall on importers and brokers, particularly around timing, post-summary corrections, and protest strategies. At the same time, global trade tensions continue to evolve, with developments involving China's regulatory posture, ongoing geopolitical risks in the Strait of Hormuz, and continued uncertainty around U.S. trade policy. Inspired by Taylor Swift's Clean, Cindy reflects on whether the industry is finally moving toward clarity after months of disruption—or simply entering a new phase of adjustment. This Week in Trade • No immediate movement on First Sale or Non-Resident Importer legislation • Continued legal and political challenges around tariff authority • China strengthens anti-foreign sanctions regulations • Ongoing uncertainty in the Strait of Hormuz impacting global shipping • Section 122 legal arguments raise questions about applicability in modern trade CAPE Launch: What You Need to Know CBP is set to roll out the CAPE process on April 20, allowing importers to begin submitting refund requests tied to IEEPA tariffs. • Filing will require only entry numbers via CSV upload • No current deadline—but high demand expected at launch • Process focuses on mechanics, not policy resolution However, key decisions remain: • Whether to file post-summary corrections before CAPE claims • How to handle entries between 80–180 days post-liquidation • Whether to file protests to preserve refund rights Open Questions for the Trade Community • How will broker systems reconcile updated ACE data? • How will CBP manage volume across 50+ million entries? • What happens to entries outside CAPE eligibility windows? • Will refunds be consistently applied across all scenarios? Cindy emphasizes that while the process is clearer, the strategy is not one-size-fits-all. Key Takeaways • CAPE is launching—but it's only part of the solution • Importers must make strategic filing decisions now • Trade compliance is shifting from uncertainty to execution mode • Clarity is emerging—but complexity remains Resources & Mentions • Global Training Center • Trade Force Multiplier Credits Host: • Cindy Allen – LinkedIn • Trade Force Multiplier Producer: • Lalo Solorzano – LinkedIn Subscribe & Follow New episodes every Friday. Presented by Global Training Center • Simply Trade Podcast on LinkedIn • Global Training Center on LinkedIn • YouTube • Spotify • Apple Podcasts • Trade Geeks Community

John is joined by Mark Wu, Henry L. Stimson Professor at Harvard Law School. They discuss the rapidly evolving legal and policy landscape surrounding U.S. tariffs following the Supreme Court's decision invalidating the President's reliance on emergency economic powers to impose broad tariffs. That ruling removed a significant set of tariffs but did not eliminate the overall tariff regime. Instead, the administration quickly pivoted to alternative statutory authorities, particularly Section 122, which permits temporary tariffs for up to 150 days, as well as longer-term mechanisms such as Section 301 and Section 232 investigations. These alternative mechanisms allow the executive branch to impose targeted tariffs based on findings related to unfair trade practices or national security concerns, with less immediate need for congressional approval.As a result, the tariff environment has shifted from sweeping, across-the-board measures to a more fragmented and dynamic system, requiring analysis on a country-by-country and product-by-product basis. Ongoing investigations into issues such as excess capacity and forced labor are likely to produce additional tariffs that may persist longer than the temporary measures currently in place. Meanwhile, legal challenges continue, including lawsuits by states arguing that the executive branch has exceeded delegated authority and violated statutory constraints. These challenges may be overtaken by the expiration of temporary tariffs and the emergence of new ones.One major issue involves refunds for tariffs previously collected under the invalidated emergency economic powers authority. Courts have indicated that refunds are warranted and administratively feasible, even at large scale, although timing remains uncertain due to potential appeals and implementation delays. Importers' entitlement to refunds from the government does not depend on whether they passed tariff costs on to customers, as the focus is on the legality of the government's action rather than downstream economic effects. Downstream purchasers who claim that invalidated tariffs were passed on to them must pursue contractual remedies rather than recovery from the government.Podcast Link: Law-disrupted.fmHost: John B. Quinn Producer: Alexis HydeMusic and Editing by: Alexander Rossi

Many medical device companies believe they have a compliant Quality Management System (QMS).On paper, everything looks perfect:• Procedures are written• Forms are available• Risk management is documented• CAPA systems are definedBut during an audit, everything falls apart.What Is a “Fake QMS”?A fake QMS is not necessarily incorrect — it is simply not implemented in reality.Employees may not understand it.Processes may not be followed.Evidence may not exist.In short:

The Wonderful World of Wine (WWW) Episode 313 Hosts Kim Simone and Mark Lenzi exploring all things wine with you! Decoding the Wine Label with Marie Cheslik Ever feel like you need a PhD and a Rosetta Stone just to pick a decent bottle of Cabernet? You aren't alone. This week on The Wonderful World of Wine(WWW), Kim and Mark sit down with Marie Cheslik, the brilliant sommelier and author behind the essential new book, “How to Read a Wine Label.” Marie isn't your average wine expert—she's a nurse and Sommelier who uses a stethoscope and corkscrew. We dive deep into the surprising parallels between the ICU and the cellar, proving that wine doesn't have to be intimidating; it just needs a little "triage."

Host: Cindy Allen Show: Simply Trade – Cindy's Version Published: April 9, 2026 Length: ~16 minutes Presented by: Global Training Center The Story of Us: Tariff Changes, CAPE Confusion, and the Trade Community Waiting for Answers Cindy Allen returns with a wide-ranging trade update set to Taylor Swift's “The Story of Us,” using the song's theme of miscommunication to frame the current disconnect between CBP, the courts, and the trade community. From a new DHS funding update and fresh uncertainty around tariffs and valuation to the evolving CAPE refund process and the latest questions around customs business, this episode captures a moment where the trade world is working hard to keep up with fast-moving policy changes. What You'll Learn in This Episode DHS and trade funding DHS remains largely unfunded, although TSA funding has now passed and some CBP officers remain funded under prior legislation. Many trade-related staff are still working without pay, and the shutdown pressure has now stretched beyond a month. Last sale and valuation debate Congress is still considering the last sale bill, which could eliminate last sale as a valuation method. Cindy explains that last sale has long been treated as part of the broader transaction value framework and is supported by court history, but Congress can still change the law if it chooses. White House tariff threats The White House floated 50% duties on countries that sell weapons to Iran, though Cindy questions what legal authority could support that now that IEEPA has been ruled unlawful. For China, the government could potentially revise Section 301 tariffs, but for other countries, the implementation path is unclear. Forced labor enforcement The Labor Department announced a new tool for assessing foreign forced labor practices, but details were sparse. Cindy notes that CBP already has a strong forced labor framework and suggests the Labor Department may be stepping into a larger detection/enforcement role. WTO criticism from USTR U.S. Trade Representative Jameson Greer published an op-ed criticizing the World Trade Organization, signaling frustration with its current effectiveness and casting doubt on the U.S. role going forward. Cindy highlights this as another sign that global trade institutions may be under pressure to prove relevance. 232 updates now in effect The recent steel and aluminum 232 changes took effect on April 6. Cindy notes that the system seems to be running smoothly, with de minimis treatment for some shipments under 15%, reduced or removed tariff coverage for certain HDS annex items, and new component-level classifications that reduce ambiguity even if the tariff burden remains high. CBP also released guidance on April 3, which importers subject to 232 should review carefully. USMCA remains strained USMCA negotiations continue, but Cindy says they are tense and may not conclude by the July 1 deadline. Despite frustration and mixed positions among the three governments, she notes the agreement still matters for North American production and U.S. manufacturing support. Customs business ruling and trade tech A recent customs business ruling has created concern among AI and trade tech companies, especially around whether certain activities now require a licensed customs broker. Cindy explains that the issue muddies the water for brokers, tech providers, and importers alike and will likely require clarification from CBP. ACE portal account requirement CBP has rolled out a new ACE portal account application process. Importers seeking refunds now need an ACE Portal account, and Cindy recommends checking CBP's site or speaking with a broker to understand the new application process. Strait of Hormuz and market impact The war with Iran is paused for two weeks, but a reported $2 million vessel toll for safe passage through the Strait of Hormuz is raising alarms. Cindy also points to Bloomberg reporting that some Asian factories are seeing 55% price increases on plastics, showing how oil transit issues ripple into fertilizers, plastics, diesel, and broader market volatility. CAPE and “The Story of Us” Cindy says she chose “The Story of Us” because the song reflects the miscommunication and silence she sees between CBP, the courts, and the trade community. The CAPE process is still being built, and while CBP has filed detailed updates with the court, the real uncertainty is how the court will interpret those filings and what rules will ultimately apply to importers. The biggest unresolved questions remain whether finally liquidated entries will be included, whether protests or court actions will be required, and how refund filings will ultimately work. Cindy notes that the lead case changed from Artemis to a new test case after Artemis withdrew, meaning the court started over with new orders and the process remains in motion. Subscribe & Follow New episodes every Friday. Presented by Global Training Center • Global Training Center on LinkedIn • YouTube • Spotify • Apple Podcasts • Trade Geeks Community

Send us Fan Mail  The new Gray Rose Company, (jointly founded by Dominic Bethel and Carl Holland), is a premium shotgun dealer and, the USA importer of Manuel Ricardo Stocks.     We sit down with Carl, who has now began the process of fitting shooters to stocks, under the expert tutelage of Ben Husthwaite. Ben and Carl discuss the stock fitting process, how Carl will offer his services across the USA, and what it means to have a Manuel Ricardo stock. Carl also fills us in on all of the services that the Gray Rose offers, aside from fitting and stocks.   While we had him there for part of the conversation, we pick Ben's brain on his thoughts of the climate of sporting clays, and where he thinks things are headed. The Gray Rose Co - https://www.grayroseco.com/Dead Pair Swag- https://x062jy-1z.myshopify.com.Kolar Arms – https://www.kolararms.com Fiocchi USA – https://fiocchiusa.comGun & Trophy Insurance – https://gunandtrophy.com/                                         Atlas Traps – https://www.atlastraps.comRhino Chokes – https://rhinochokes.comRanger Shooting Eyewear – https://www.reranger.com   Ranger 10% Discount = DEADPAIR10Taconic Distillery – https://www.spirits.taconicdistillery.com/  Discount -DEADPAIR10Long Range – https://www.longrangellc.comMidwayUSA Foundation - https://www.midwayusafoundation.orgSlick Products – https://www.slickproductsusa.com/deadpair     ElJefe Energy – https://www.eljefe.com OtoPro Technologies - https://otoprotechnologies.comBarepelt - https://barepelt.comScore Chaser – https://scorechaser.com/NSSF Plus One – https://www.nssf.org/plusone/                                                              Clay Range Design Works – https://traptowers.coSupport the showThe Dead Pair Podcast - https://thedeadpair.com  FACEBOOK- https://www.facebook.com/Thedeadpair. INSTAGRAM- https://www.instagram.com/thedeadpairpodcast/YOUTUBE- https://youtube.com/channel/UCO1ePh4I-2D0EABDbKxEgoQ

Importing isn't as simple as buying a product overseas and having it show up at your door. In this episode of Simply Trade, Lalo Solorzano and Andy Shiles break down three of the most common (and costly) assumptions business owners make about importing—and how those mistakes can quietly erode margins, create compliance risk, and lead to serious problems with U.S. Customs. If you're importing—or thinking about it—this is a must-listen.

Amazon or Walmart didn't defeat the tariffs. Victor Schwartz, the small New York-based wine importer who founded VOS Selections, filed suit shortly after they were announced. He took the case all the way to Supreme Court and won. Is there a guest you want us to interview? A topic you want us to cover? We want to hear from you! Email us at podcast@wineenthusiast.com. Remember to rate and review us on Apple Podcasts, Spotify, or wherever you listen to podcasts. Go to WineEnthusiast.com for the latest beverage industry coverage and all the tools you need to bring your love of wine to life. And wait, there's more! Get over 70% OFF the original cover price by subscribing to Wine Enthusiast magazine today!    FOLLOW US: TikTok: @wineenthusiast Instagram: @wineenthusiast Facebook: @WineEnthusiast

Artificial Intelligence is rapidly transforming the medical device industry, enabling smarter diagnostics, predictive analytics, and personalized healthcare solutions. However, with this innovation comes increased regulatory complexity.In this episode, Camille Petri shares insights into how Notified Bodies assess AI-based medical devices and what manufacturers need to prepare for successful certification.Are AI Devices More Difficult to Certify?Compared to traditional software, AI-based medical devices introduce additional layers of complexity. These include data dependency, algorithm behavior, and potential variability in performance.Notified Bodies are therefore placing greater emphasis on transparency, traceability, and robustness.Data: The Foundation of AI CertificationOne of the most critical elements in AI certification is the quality of data.Manufacturers must clearly document:• Training datasets• Validation datasets• Test datasetsCommon deficiencies include poor dataset representativeness, lack of traceability, and insufficient justification of data selection.Clinical Evaluation for AIClinical evaluation for AI devices differs from traditional approaches.Regulators may accept retrospective data in some cases, but increasingly expect strong clinical evidence demonstrating real-world performance.The challenge lies in proving that the AI system performs consistently across different populations and use cases.Risk Management in AIAI introduces new types of risks, including:• Algorithm bias• Performance drift over time• Lack of explainabilityManufacturers must integrate these risks into their risk management process, in line with ISO 14971.Performance, Validation & Continuous LearningA key question for regulators is how to manage AI systems that evolve over time.Notified Bodies often differentiate between:• Locked algorithms (fixed behavior)• Continuous learning systems (adaptive models)Each approach has different regulatory implications, particularly regarding validation and post-market monitoring.Key TakeawayAI in MedTech offers tremendous opportunities, but certification requires a strong foundation in data, clinical evidence, and risk management.Understanding what Notified Bodies expect early in development can significantly improve your chances of a successful submission.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkCamille Petri Linkedin: https://www.linkedin.com/in/camillepetri/Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=trueSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

Host: Cindy Allen Published: April 3, 2026 Length: ~15 minutes Presented by: Global Training Center Summary In this week's episode of Simply Trade: Cindy's Version, Cindy Allen breaks down a major shift in trade operations as CBP moves closer to launching the CAPE system for IEEPA duty refunds—while at the same time, new Section 232 actions signal that trade enforcement is far from slowing down. CBP has indicated it is on track for an April 20 rollout of CAPE, with key components nearing completion. However, Phase 1 will only cover certain entries, leaving many importers navigating critical decisions around protests and timing. At the same time, new developments in pharmaceutical tariffs and steel and aluminum revisions suggest that, despite recent legal challenges, trade enforcement is evolving—not retreating. Inspired by Taylor Swift's Begin Again, Cindy walks through why this moment feels less like closure—and more like the start of a new phase in global trade compliance. This Week in Trade • CBP signals April 20 target for CAPE rollout tied to IEEPA refunds • Phase 1 expected to cover ~63% of entries, excluding many already liquidated cases • Judge highlights importers' right to file protests, raising strategic considerations • Strait of Hormuz disruptions continue to create supply chain uncertainty • No movement on key legislation including First Sale and Foreign Importer of Record rules IEEPA Refunds & CAPE: Where Things Stand CBP continues to make progress toward launching CAPE (Consolidated Administration and Processing of Entries): • Claim portal (~85% complete) • Mass processing of entries (~60% complete) • Review and liquidation (~80% complete) • Refund processing (~75% complete) Phase 1 will: • Focus on unliquidated entries and those within voluntary reliquidation windows • Exclude fully liquidated entries, protests, drawback, and certain AD/CVD cases ⏱️ Timeline: • Target launch: ~April 20 • Estimated processing: up to 45 days post-launch Section 232: We're “Beginning Again” This week brought significant new developments under Section 232: Pharmaceutical Tariffs • 100% duty on name-brand pharmaceuticals • Generics excluded • Implementation expected within 180 days Key complexity: • Importers must now identify brand vs. generic at entry • Multiple exemptions and reduced rates tied to reshoring and trade agreements Steel & Aluminum Updates • 50% duty remains for core steel/aluminum products • 25% duty on derivative products (full value) • New de minimis exemption for products with

On February 6, 2026, U.S. Customs and Border Protection (CBP) transitioned to electronic-only refunds.  Has your company done what it needs to do to ensure it receives the refunds it deserves? 

Hosts: Renee Chiuchiarelli & Julie Parks Format: Simply Trade Tips Length: ~12 minutes Episode Summary Renee and Julie break down how organizational structure—centralized, decentralized, matrix, or hybrid—directly impacts compliance success. Learn practical "tweaks" to move customs from a reactive support function to a proactive strategic partner. Key Takeaways & Fixes 1. Centralized Structure The Issue: Customs reacts to problems after decisions are made. The Fix: Embed controls upstream; ensure Customs has authority, not just execution duties.

As part of the government's response to the oil crisis, ministers are meeting with fuel importers today to discuss possible changes to fuel specifications. Energy expert David Keat was a manager at the now-shuttered Marsden Point refinery. He spoke to Ingrid Hipkiss.

The country's biggest fuel import terminal says there's no need to panic over our fuel supply. Channel Infrastructure, at Marsden Point, can store 300 million litres on its Northland site, which is about a 30 days supply for Northland and Auckland. Chief executive Rob Buchanan spoke to Ingrid Hipkiss.

Host: Cindy Allen Published: March 13, 2026 Length: ~15 minutes Presented by: Global Training Center Episode Summary In this week's episode of Simply Trade: Cindy's Version, Cindy Allen breaks down the latest developments following the Supreme Court's decision striking down IEEPA tariffs—and what CBP is proposing as a path forward for duty refunds. CBP has introduced a proposed automated system called CAPE (Consolidated Administration Processing of Entries) to manage refund claims tied to the invalidated tariffs. While the proposal answers some questions, it also raises several new operational considerations for importers and customs brokers. At the same time, global trade policy continues to move quickly. The administration has launched new Section 301 investigations covering 16 major economies, announced forced labor investigations involving 60 countries, and is monitoring supply chain risks tied to oil disruptions in the Strait of Hormuz. Inspired by Taylor Swift's This Is Me Trying, Cindy walks through what we know, what we don't know yet, and why the trade community may need to remain patient as the refund process takes shape. This Week in Trade • New Section 301 investigations targeting structural excess manufacturing capacity across 16 economies • Forced labor investigations announced involving 60 countries • Ongoing monitoring of supply chain risks tied to the Strait of Hormuz • Possible Jones Act waiver discussions as energy logistics concerns grow IEEPA Refund Process: What We Know So Far Following the Supreme Court decision, CBP has proposed a new automated refund system called CAPE, which would allow importers or brokers to submit claims through a portal connected to ACE. The proposal includes: • A portal-based refund submission process • Automated recalculation of entries with IEEPA duties removed • Updated entry records reflected back into ACE While the framework is promising, several operational questions remain—including how already liquidated entries, reconciliation filings, and broker system updates will be handled. Key Takeaways • CBP is developing a structured process for IEEPA duty refunds • Importers will likely need to submit claims through a CAPE portal • Some refund scenarios remain unclear and may require legal guidance • Major new Section 301 investigations signal continued trade enforcement activity • Global supply chain risks remain elevated due to energy disruptions Credits Host: Cindy Allen - Trade Force Multiplier Producer: Lalo Solorzano Simply Trade is produced by Global Training Center Subscribe & Follow • YouTube • Spotify • Apple Podcasts Join the conversation with fellow trade professionals in the Trade Geeks Community: https://globaltrainingcenter.com/portal/?utm_source=SimplyTradePodcast

In this episode, we dive into Union Pacific CEO Jim Vena's defense of the proposed $85 billion merger with Norfolk Southern, which he claims will vastly improve rail efficiency and convert two million truckloads to rail annually. Despite an initial rejection from the Surface Transportation Board, the rail companies are gearing up to file an updated application this April. Next, we cover the growing legal battle where a coalition of 24 states and major corporations are suing the Trump administration over sweeping 10% import tariffs. Importers like Nintendo and Costco are seeking billions in refunds, arguing that the administration unlawfully bypassed Congress to levy these emergency duties. Finally, we examine how the war in Iran has severely disrupted ocean freight, prompting the world's largest shipping line to terminate all Arabian Gulf voyages. With the Strait of Hormuz effectively closed, MSC is diverting shipments to safe ports and hitting shippers with a mandatory $800 surcharge per container to cover deviation costs. Follow the FreightWaves NOW Podcast Other FreightWaves Shows Learn more about your ad choices. Visit megaphone.fm/adchoices

Non-resident importers of record need to rethink that status. A new bill will limit NIRs requiring resident status. Listen for more on Two Minutes in Trade. 

IEEPA tariff refunds are coming…but in ACE years. So, how long is that?  Listen for more on Two Minutes in Trade. 

This Day in Legal History: The AmistadOn March 9, 1841, the U.S. Supreme Court decided United States v. The Amistad, ruling that a group of Africans who had seized control of the Spanish ship La Amistad were free individuals who had been illegally enslaved. The case began after the captives, led by Sengbe Pieh—often called Cinqué—revolted against the ship's crew while being transported from Cuba in 1839. They had originally been kidnapped in West Africa and sold into slavery in violation of international agreements banning the transatlantic slave trade. After the revolt, the ship was intercepted near Long Island and the Africans were taken into U.S. custody. Spanish officials demanded that the United States return both the ship and the captives to Cuba. The U.S. government supported Spain's request, arguing that the captives were property under Spanish law.Abolitionists rallied to the Africans' defense and secured legal representation for them in American courts. The case eventually reached the Supreme Court, where former President John Quincy Adams joined the legal team arguing for the captives' freedom. Adams delivered a lengthy and passionate argument emphasizing natural rights and the illegality of the slave trade that had brought the Africans to Cuba. Writing for the majority, Justice Joseph Story concluded that the captives had been unlawfully enslaved and were therefore not property. Because they were free individuals, the Court held that they had the legal right to resist their captivity and fight for their liberty. The Court ordered that the Africans be released rather than returned to Spanish authorities.The ruling was celebrated by abolitionists as an important moral and legal victory in the fight against slavery. Although it did not end slavery in the United States, the decision demonstrated that courts could recognize limits on the slave trade and acknowledge the legal claims of enslaved people.Thirteen major U.S. book publishers have filed a copyright lawsuit against Anna's Archive, a website they describe as one of the largest “shadow libraries” distributing pirated books and academic papers. The publishers—including HarperCollins, Wiley, McGraw Hill, and Cengage—filed the complaint in federal court in New York, alleging that the site hosts more than 63 million books and 95 million research papers without authorization. According to the lawsuit, Anna's Archive allows users to download these materials directly or through torrent networks, making copyrighted works widely available for free. The publishers claim the site openly presents itself as a pirate platform and intentionally violates copyright law.The complaint also alleges that Anna's Archive was created in 2022 after copying entire collections from other illegal book repositories and has continued expanding its database. The publishers say the site operates anonymously and frequently changes domain names across different countries to avoid enforcement efforts. They further claim the platform targets artificial intelligence developers by offering large datasets of books and papers. While free users can access files slowly, the complaint states that faster downloads are available to users who make donations through untraceable methods like cryptocurrency or gift cards. The publishers allege that these donations can reach roughly $200,000 for high-speed bulk access. In response, the plaintiffs are asking the court to shut down the site and award statutory damages of up to $150,000 for each infringed work.The lawsuit follows a separate case brought by Atlantic Recording Corp., which earlier obtained a preliminary injunction preventing Anna's Archive from distributing millions of music files allegedly copied from Spotify. That case resulted in a default after the site failed to respond to the complaint. However, the publishers argue that the earlier injunction does not cover books, allowing the alleged book piracy to continue. The Association of American Publishers has publicly supported the lawsuit, describing the scale of digital piracy as extremely large and urging legal action to stop the operation.Publishers Sue ‘Shadow Library' For ‘Staggering' Book Piracy - Law360Companies that operate in California are facing uncertainty as the state moves forward with major climate disclosure laws while a federal appeals court considers whether the rules should be blocked. The laws—California Senate Bills 253 and 261—require large companies doing business in the state to disclose information about greenhouse gas emissions and climate-related financial risks. In late February, the California Air Resources Board approved initial regulations explaining how the reporting system will be administered and how companies will pay implementation fees. At the same time, the Ninth Circuit has temporarily blocked enforcement of S.B. 261 and is reviewing a request from business groups to halt both laws entirely.Because of this parallel regulatory and legal process, many companies are unsure whether they should invest heavily in compliance or wait for the courts to rule. S.B. 253 applies to companies with more than $1 billion in annual revenue and requires reporting of Scope 1, Scope 2, and Scope 3 greenhouse gas emissions, which include direct emissions, energy-related emissions, and emissions from supply chains. S.B. 261 applies to companies with more than $500 million in revenue and requires disclosure of climate-related financial risks and mitigation strategies. Attorneys say collecting this data could be difficult, especially for companies that only have limited operations in California or that must gather information from suppliers and partners in other regions.The reporting requirements could also affect businesses outside California because companies subject to the law may need emissions data from their partners and vendors. Regulators have begun setting deadlines for initial reporting, including an August deadline for certain emissions data, but many details about how the system will function remain unresolved. Meanwhile, business groups including the U.S. Chamber of Commerce argue the laws violate the First Amendment by forcing companies to speak on controversial issues related to climate change. With rulemaking still underway and litigation ongoing, companies are left trying to prepare for possible compliance while waiting to see whether the courts ultimately uphold or invalidate the laws.Companies In Limbo Over Calif. Climate Disclosure Laws' Fate - Law360In a major California bellwether trial over claims that social media harms children's mental health, the plaintiff has finished presenting her case against Instagram and YouTube. The plaintiff, a 20-year-old referred to as Kaley G.M. to protect her identity, alleges that features on the platforms contributed to anxiety, depression, and body dysmorphia she experienced as a minor. Her attorney, Mark Lanier, chose not to call Kaley's mother to testify live, instead presenting a brief portion of her deposition to the jury. The decision appeared partly influenced by strict time limits imposed by the judge during the trial. In the deposition testimony, the mother acknowledged she had little knowledge of her daughter's social media use and did not monitor her phone because she viewed it similarly to a household landline.Defense attorneys have argued that Kaley's mental health problems were caused by difficulties at home rather than the platforms themselves. Evidence introduced at trial suggested the plaintiff had conflicts with her mother, including allegations of neglect, verbal abuse, and limited supervision of internet use. The defense also pointed to bullying and other personal issues as alternative explanations for the plaintiff's struggles. Meanwhile, a former Meta employee testified that internal company information suggested Instagram could be addictive and harmful to young users, although defense lawyers challenged his credibility and the extent of his involvement with safety issues.The plaintiff's final expert witness discussed ways social media companies could design safer platforms for children. After the plaintiff rested, Meta began presenting its defense with testimony from school administrators connected to the plaintiff. The case is the first bellwether trial among thousands of similar lawsuits consolidated in California, with outcomes potentially shaping settlement negotiations and future trials. TikTok and Snap previously settled with this plaintiff, but the broader litigation against social media companies continues.Meta, Google Begin Defense As Mental Harm Plaintiff Rests - Law360 UKThe U.S. Customs and Border Protection (CBP) agency told a federal trade court that it expects to create a system within about 45 days to process refunds for tariffs that were previously imposed under President Donald Trump and later ruled unconstitutional by the U.S. Supreme Court. The tariffs generated roughly $166 billion in payments from about 330,000 importers, and the Court's decision did not specify how those funds should be returned. As a result, government lawyers and a judge from the U.S. Court of International Trade are working to establish a practical process for issuing refunds.Under the proposed plan, importers would submit a declaration through CBP's electronic system detailing the tariffs they paid. The agency would verify the information and then issue a single payment from the Treasury Department to each importer, including interest. Officials say this approach would avoid forcing businesses to file individual lawsuits to recover their money. The judge overseeing the matter recently modified an earlier order that required immediate refunds, acknowledging that the agency needs time to build a workable system.CBP explained that its current administrative system cannot automatically process refunds on the massive scale required. Importers paid tariffs on more than 53 million shipments, and manually reviewing each transaction could require millions of hours of labor. Several large companies, including affiliates of Nintendo and CVS, have already filed lawsuits seeking repayment, though the government hopes a broader refund system will resolve claims more efficiently.Business groups such as the U.S. Chamber of Commerce have supported the proposal, saying it could simplify the process for smaller companies. However, officials noted that relatively few importers have registered for the electronic refund system created earlier this year. The court continues to oversee the development of the refund process through a test case that could guide how payments are returned to all affected businesses.US customs agency expects tariff refund system to be ready in 45 days | Reuters This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.minimumcomp.com/subscribe

Host: Cindy Allen Show: Simply Trade – Cindy's Version Published: March 6, 2026 Length: ~13 minutes Presented by: Global Training Center Ready For It? CBP's IEEPA Refund Proposal Drops—Here's What's Next Cindy Allen, CEO of TradeForce Multiplier, dives into the latest trade developments through Taylor Swift's “Ready For It?”—perfect for the “let the games begin” drama unfolding in IEEPA refund hearings. From DHS shakeups and Section 122 lawsuits to CBP's just‑filed refund blueprint, Cindy unpacks the mechanics, open questions, and what importers/brokers should do now.​ What You'll Learn in This Episode DHS leadership change Secretary Noem removed; scuttlebutt suggests more exits at DHS/CBP headquarters. New nominee: Oklahoma senator with broad congressional/President support (not yet formal).​ Section 122 tariff challenges 24 states sue in Court of International Trade, arguing Section 122 doesn't meet “imbalance of payments” requirement for universal tariffs. Commerce Secretary Besant hints at 15% rate hikes for specific industries, potentially violating Section 122's uniform application rule—no movement yet (as of Friday afternoon).​ USMCA signals Congress supports extension, but President has final say. Discussions on trilateral vs. bilateral (U.S.–Canada, U.S.–Mexico); some push for 1‑year extension to renegotiate post‑tariff chaos.​ Global disruptions Iran war halts Strait of Hormuz traffic, backing up oil tankers and vessels reliant on that fuel—broad transportation ripple effects.​ USTR advisory opportunity Nominations open for 4 USTR trade advisory groups (separate from COAC)—check Federal Register notices. Chance to influence policy, build government/industry relationships.​ Why “Ready For It?” Cindy channels Taylor Swift's “Ready For It?” for the IEEPA refund “dating game” between DOJ, CBP, and CIT: Federal Circuit rejected government's 90‑day delay request, remanded immediately to CIT. CIT hearing (March 4) was “entertaining” bickering—judge ruled no suit needed for non‑final entries and ordered CBP to liquidate without IEEPA duties. CIT conference (March 6, closed): CBP filed a refund proposal.​ CBP's IEEPA Refund Proposal Breakdown How it would work: Importers file ACE declaration with Excel list of affected entries. ACE runs validations, auto‑recalculates IEEPA refund. CBP verifies declaration accuracy. ACE auto‑liquidates; CBP certifies; Treasury issues refunds (as normal). Estimated 45 days for CBP programming.​ Open questions: Entry updates: ACE is system of record—will underlying entry summaries be corrected? (Critical for protests, PSCs, reconciliation, drawback.) Broker involvement: ABI required? Broker systems need programming? Push/pull updates? Reconciliation: How handled in bulk process? PSC/audit impact: Can filers still correct misclassifications post‑bulk liquidation? (Protests harder than PSC.) Liquidation halt: CBP questions authority to pause during 45‑day programming (hundreds of thousands liquidated March 6).​ Key Takeaways CIT has jurisdiction; expect CBP proposal review/dialogue—trade associations pushing entry updates. Programming delays + ABI sync = potential months before refunds flow. Liquidation is automatic unless stopped—monitor your entries closely. “Let the games begin”—are you ready for the IEEPA refund process?​ Credits Host: Cindy Allen Producer: Annik Sobing  Listen & Subscribe Simply Trade main page: https://simplytrade.podbean.com​ Apple Podcasts: https://podcasts.apple.com/us/podcast/simply-trade/id1640329690​ Spotify: https://open.spotify.com/show/09m199JO6fuNumbcrHTkGq​ Amazon Music: https://music.amazon.com/podcasts/8de7d7fa-38e0-41b2-bad3-b8a3c5dc4cda/simply-trade​ Connect with Simply Trade Podcast page: https://www.globaltrainingcenter.com/simply-trade-podcast​ LinkedIn: https://www.linkedin.com/showcase/simply-trade-podcast​ YouTube: https://www.youtube.com/@SimplyTradePod​ Join the Trade Geeks Community Trade Geeks (by Global Training Center): https://globaltrainingcenter.com/trade-geeks/  

In this episode: Republican leaders in the Florida House of Representatives are trying to lawyer their way out of taking some tough votes — including on whether or not to fix Senate Bill 180, a hurricane-recovery law that real-estate developers have been using to crush local environmental regulations. Plus: Not one but two favors for the car dealer lobby. And why are some Florida lawmakers pushing to make condo owners pay higher prices for property insurance? (The answer rhymes with “millionaire.”) An update from Day 51 of Florida's 2026 legislative session.Show notesThe bills discussed in today's show: Senate Bill 840 — Land Use Regulations for Local Governments Affected by Natural DisastersSenate Bill 1756 — Medical FreedomSenate Bill 180 (2025) — EmergenciesHouse Bill 1001 (2025) — VesselsSenate Bill 1388 (2025) — VesselsHouse Bill 291 — Common Entities of Motor Vehicle Distributors and ManufacturersSenate Bill 352 — Common Entities of Motor Vehicle Distributors and ManufacturersHouse Bill 989 — Motor Vehicle Manufacturers, Importers, and Distributors and Franchised Motor Vehicle DealersPassed the House of Representatives by a 109-1 vote (vote sheet)Senate Bill 1028 — Citizens Property Insurance CorporationPassed the Florida Senate by a 33-1 vote (vote sheet)Senate Bill 620 — Candidate QualifyingPassed the Florida Senate by a 37-0 vote (vote sheet)House Bill 655 — Pub. Rec. and Pub. Meetings/Attorney Meetings to Discuss Private Property Rights ClaimsPassed the Senate by a 36-0 vote (vote sheet)House Bill 981 — Tributaries of St. Johns RiverPassed the House of Representatives by a 107-3 vote (vote sheet)House Bill 725 — Political Activity at Public Institutions of Higher EducationPassed the House of Representatives by an 81-30 vote (vote sheet)The stories discussed in today's show:Ron DeSantis is helping real estate developers exploit a hurricane relief lawThe last stand for home rule in Florida (podcast)Orders from on highNew State Law Forces Wellington To Change Waterway RulesCar dealers try to keep a chokehold on new car sales in FloridaRepublican megadonor is behind bill that could affect Florida condo ownersQuestions or comments? Send ‘em to Garcia.JasonR@gmail.comListen to the show: Apple | SpotifyWatch the show: YouTube Get full access to Seeking Rents at jasongarcia.substack.com/subscribe

The global medical device regulatory environment is complex, often requiring manufacturers to repeat similar submissions and audits across multiple countries. This duplication slows innovation and delays patient access to life-saving technologies.To address this challenge, international regulators are increasingly collaborating through the International Medical Device Regulators Forum (IMDRF).In this podcast episode, Stephanie Grassmann (MedTechXperts) joins us to discuss how the concept of Regulatory Reliance is transforming global medical device approvals.What is IMDRF?The International Medical Device Regulators Forum (IMDRF) is a voluntary group of regulatory authorities working together to harmonize medical device regulations and reduce duplication across global markets.Members include major regulatory bodies such as:• United States (FDA)• European Union• Australia (TGA)• Brazil (ANVISA)• Canada (Health Canada)• China (NMPA)Their mission is to promote efficient regulation while maintaining high standards of safety and performance.Understanding Regulatory RelianceRegulatory reliance allows one authority to give significant weight to the work already performed by another trusted regulator.Instead of repeating full assessments, authorities can leverage existing evaluations, reducing regulatory burden while maintaining confidence in safety and effectiveness.Real-World Success StoriesSeveral regulators are already demonstrating the benefits of reliance mechanisms.Australia – TGAA Class III Mitral Valve Clip reached market access in just 20 working days after the regulator accepted evidence generated overseas.Argentina – ANMATDental instruments known as endodontic barbed broaches were approved in 9 working days using reliance pathways.Brazil – ANVISACompanies holding MDSAP certification may skip immediate on-site audits, saving both time and money during market entry.These examples show how regulatory cooperation can significantly accelerate approvals.The Role of MDSAPThe Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single regulatory audit recognized by multiple countries.This program plays a key role in enabling reliance between regulatory authorities and reducing redundant inspections.The European PerspectiveEurope has historically maintained a distinct regulatory framework under EU MDR and IVDR.However, recent proposals—including references to Articles 108a and 108b—suggest increasing collaboration with international frameworks such as IMDRF and MDSAP.While a single global approval system remains a long-term goal, reliance initiatives are already demonstrating that cooperation between regulators can improve efficiency without compromising safety.Looking AheadFor manufacturers and startups, embracing international regulatory frameworks early—such as MDSAP and IMDRF guidance—can significantly improve global market access strategies.As regulatory collaboration grows, the future of medical device approvals may become faster, more harmonized, and more patient-centered.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkStephanie Grassmann Linkedin: https://www.linkedin.com/in/stephaniegrassmann-medtechxperts/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

Hosts: Lalo Solorzano Guests: Eric Hargraves – Elliott Davis Cindy Allen – Trade Force Multiplier Mark Segrist – Sandler, Travis & Rosenberg Recorded Live At: The International Compliance Professionals Association (ICPA) Annual Conference in San Antonio. Episode Summary In this special live conference episode, Lalo sits down with three trade experts at the ICPA Annual Conference to unpack one of the biggest trade law developments in years: the Supreme Court ruling limiting the use of IEEPA for tariff authority. Together, Eric Hargraves, Cindy Allen, and Mark Segrist break down what the decision actually means, how the administration pivoted immediately to other tariff tools, and why importers should not assume refunds are guaranteed. The conversation dives into the legal fallout, enforcement uncertainty, and compliance strategies companies should be thinking about right now, including protests, litigation strategies, and how trade compliance is rapidly becoming a C-suite level issue. If you're trying to understand the real-world impact of the ruling, tariff stacking, and what actions importers should be taking today, this discussion delivers practical insight straight from the conference floor. Key Takeaways The Supreme Court Limited Presidential Tariff Authority Under IEEPA The Court ruled that the president cannot impose tariffs using IEEPA, emphasizing that taxation powers belong to Congress under the Constitution. The Administration Immediately Pivoted to Other Tools With IEEPA tariffs struck down, the administration quickly shifted toward Section 122 and other statutory authorities, showing that tariff policy will continue through different mechanisms. Tariff Stacking and Complexity Are Increasing Importers now face potential layers of tariffs under Section 232, Section 301, Section 122, and other mechanisms, making duty calculations and compliance far more complex. Refunds Are Not Guaranteed Even though the ruling invalidated certain tariffs, experts warn that refunds are not automatic, and companies must actively preserve their rights. Importers Must Take Action Now Companies should be monitoring liquidation dates, filing protests when necessary, and considering litigation options to protect their ability to recover duties. Trade Compliance Is Now a Strategic Function Trade and customs issues have moved from back-office compliance work to strategic discussions at the executive level, impacting supply chains, costs, and global operations. Notable Topics Discussed The Supreme Court decision on IEEPA tariffs Section 122 as the administration's immediate fallback tool How tariff stacking affects real duty rates Litigation strategies and the growing role of the Court of International Trade Why companies should file protests and protect their refund rights The rise of trade compliance as a strategic corporate function Resources & References International Compliance Professionals Association (ICPA) ICPA on LinkedIn ICPA LinkedIn Group About the Guests Eric Hargraves A trade and customs specialist with Elliott Davis who advises companies on navigating complex regulatory frameworks and trade enforcement issues. Cindy Allen Founder of Trade Force Multiplier and a leading voice in customs compliance, supply chain strategy, and global trade education. Mark Segrist Attorney with Sandler, Travis & Rosenberg focusing on international trade law, customs regulations, and tariff litigation. Join the Conversation What do you think this ruling means for importers and future tariff policy? Join the discussion and share your thoughts with the Simply Trade community. Credits Host: Lalo Solorzano Guests: Eric Hargraves Cindy Allen Mark Segrist Produced by: Global Training Center Subscribe & Follow Follow Simply Trade to stay updated on the latest insights in global trade and customs compliance. YouTube: https://www.youtube.com/@simplytradepod Spotify: https://open.spotify.com/show/09m199JO6fuNumbcrHTkGq Apple Podcasts: https://podcasts.apple.com/us/podcast/simply-trade/id1640329690 Connect With Us Lalo Solorzano: https://www.linkedin.com/in/lalosolorzano/ Andy Shiles: https://www.linkedin.com/in/andyshiles/ Global Training Center: https://www.linkedin.com/company/global-training-center Join the Trade Geeks community: https://globaltrainingcenter.com/portal/

This week we begin by looking at who imports the most from China (5:17), why Chinese spend so much money on food (13:30), and Dictator Xi’s next CCP purge (18:38). Then, we take a deep dive (23:00) into the breaking story of the former US Air Force pilot who was arrested in February after returning from 2+ years of sharing military secrets with the Communist regime in Beijing. Lastly, we look at this week’s diverse list of Chinese cities to be praying for (42:36)! Welcome to China Compass on the Fight Laugh Feast network! I'm your China travel guide in exile, Missionary Ben. Follow me on X (@chinaadventures) where I share a new Chinese city or county to pray for every single day. Feel free to write anytime: chinacompass@privacyport.com. All my books, substack, patreon, and everything else can be easily found at PrayGiveGo.us! Book Recommendation: “I'm currently reading [The Millionaire Missionary] and am really enjoying it. What a powerful story of radical obedience and sacrifice. I'm planning to recommend it to the young men I'm currently mobilizing for the 10/40 Window—I think Borden's example will be incredibly inspiring for them as they consider their own call to the unreached.” The Autobiography of John G. Paton (JohnGPaton.com) Borden of Yale: The Millionaire Missionary (BordenofYale.com) Unbeaten: Arrested, Interrogated, and Deported from China (Unbeaten.vip) How Dependent is Each Country on Chinese Imports? https://www.visualcapitalist.com/mapped-countries-most-dependent-china-imports/ Why Chinese People Spend So Much On Food (Paywall) https://www.economist.com/finance-and-economics/2026/02/26/why-chinese-people-spend-so-much-on-food Xi’s Next Purge Immanent (Paywall) https://asia.nikkei.com/editor-s-picks/china-up-close/analysis-rumors-abound-over-xi-s-next-purge-target-ahead-of-npc Former US Airforce Pilot Arrested for Training Chinese Military Pilots https://www.justice.gov/opa/pr/former-us-air-force-pilot-arrested-providing-defense-services-chinese-military Here's a look at this coming week's Pray for China (PrayforChina.us) cities… https://chinacall.substack.com/p/pray-for-china-mar-1-7-2026 Thank you for listening! Subscribe and leave a review on your favorite podcast platform! There’s also a Paypal link at PrayforChina.us if you’d like to give to our China ministry. Last but not least, for (almost) everything else we’re doing visit PrayGiveGo.us. Luke 10, vs 2: the harvest is plentiful but the workers are few, therefore ask the Lord for more. Talk again soon!

Host: Cindy Allen Show: Simply Trade – Cindy's Version Published: February 27, 2026 Length: ~15 minutes Presented by: Global Training Center All Too Well: One Week Post-IEEPA, Still Not Fine at All One week after the Supreme Court struck down IEEPA tariffs, Cindy Allen, CEO of TradeForce Multiplier, delivers the latest update through the lens of Taylor Swift's “All Too Well.” She breaks down the lingering uncertainty—“I know it's long gone and the magic's not here no more… I might be okay, but I'm not fine at all”—and what importers, brokers, and service providers should do next amid shutdowns, pending bills, and shifting tariff authorities.​ What You'll Learn in This Episode Legislative landscape Three new bills introduced on IEEPA refunds: two support refunds for importers; one opposes and ties refunds to consumers (challenging in practice). Other pending bills (eliminating first sale, non‑resident importer status, new licensing program) are unlikely to move soon. IEEPA refund bills could gain traction if courts rule against refunds—watch for Congress to act.​ DHS shutdown impacts Ongoing due to budget issues; most CBP personnel are working without pay (be kind!). Trade interactions limited as “non‑essential”: canceled meetings, no new conference appearances. TSA PreCheck spared (shutdown threat revoked); Global Entry inactive due to staffing.​ CBP updates and waits Still awaiting Section 232 valuation guidance for steel/aluminum/copper derivatives—current CBP direction conflicts with executive order language. Trade associations have jointly requested clarity; no response yet.​ Administration signals New trade deals now using Section 122 authority instead of IEEPA. Acceleration planned for remaining 232 investigations and new 301 actions—structured processes with timelines, public input, and notice (no more Friday night surprises).​ Why “All Too Well”? Cindy ties the week to Taylor Swift's “All Too Well,” capturing trade's emotional whiplash: IEEPA is “long gone,” but the “magic” of predictability isn't back. Importers, attorneys, and consultants are swamped with “What now?” calls—Cindy's attended 5+ webinars with no clear answers. The trade isn't “fine”—we're in uncharted territory.​ The Big Questions: If, How, When on IEEPA Refunds IF refunds happen: Supreme Court remanded to lower court, likely landing at Court of International Trade (CIT). Prevailing view: no legal basis to withhold refunds, but scope (“which refunds?”) is unclear.​ HOW to get refunds: Two paths debated: 1581(i) (equitable jurisdiction—broad refunds for all) vs. 1581(a)(denied protests only). Post-summary corrections rejected by CBP—don't try now. FedEx filed CIT action to protect refund rights. Recommendation: talk to an attorney for tailored advice.​ WHEN to act: Government has 25 days for rehearing request (unlikely); ~7 days admin time; then CIT jurisdiction (~32 days total from Supreme Court). File protests now if entries liquidate soon to preserve rights (CIT may require it under 1581(a)). If no imminent liquidations, wait—process could take months or a year+. Pack patience; this is a long haul.​ Key Takeaways IEEPA tariffs are history, but uncertainty reigns—new authorities (Section 122, accelerated 232/301) fill the gap.​ Support CBP/TSA workers during shutdown—they're on the job unpaid.​ Consult an attorney ASAP for refund strategy; don't sleep on protest deadlines.​ No quick fixes ahead—trade pros need patience and planning.​ Credits Host: Cindy Allen Producer: Annik Sobing Listen & Subscribe Simply Trade main page: https://simplytrade.podbean.com​ Apple Podcasts: https://podcasts.apple.com/us/podcast/simply-trade/id1640329690​ Spotify: https://open.spotify.com/show/09m199JO6fuNumbcrHTkGq​ Amazon Music: https://music.amazon.com/podcasts/8de7d7fa-38e0-41b2-bad3-b8a3c5dc4cda/simply-trade​ Connect with Simply Trade Podcast page: https://www.globaltrainingcenter.com/simply-trade-podcast​ LinkedIn: https://www.linkedin.com/showcase/simply-trade-podcast​ YouTube: https://www.youtube.com/@SimplyTradePod​ Join the Trade Geeks Community Trade Geeks (by Global Training Center): https://globaltrainingcenter.com/trade-geeks/

John is joined by Dennis H. Hranitzky, partner in Quinn Emanuel's Salt Lake City office, and Fritz Scanlon, of counsel in Quinn Emanuel's Washington, D.C. office. They discuss the recent Supreme Court decision invalidating all tariffs President Trump imposed under the International Emergency Economic Powers Act (IEEPA). IEEPA tariffs had generated an estimated $160 billion in revenue and were central to the administration's tariff policy.The administration justified these tariffs based on declared national emergencies, including fentanyl trafficking and persistent trade deficits. The Court did not rule on whether those circumstances constituted true emergencies. Instead, the Court held that the tariffs were invalid because the Constitution assigns all taxing authority to Congress, and the IEEPA did not expressly grant the President the power to impose tariffs.In response to the Supreme Court's ruling, the administration has now turned to other statutes, including Section 122 of the Trade Act of 1974, which allows temporary tariffs of up to 15 per cent for 150 days to address balance-of-payments concerns. Other tools, such as Section 232 of the Trade Expansion Act of 1962, permit product-specific tariffs tied to national security findings, but require administrative investigations and procedural safeguards. These mechanisms provide less unilateral flexibility than IEEPA had afforded.John, Dennis, and Fritz also discuss the prospects for companies obtaining refunds through litigation. Importers who directly paid the invalidated tariffs appear to have strong claims for reimbursement, primarily through the U.S. Court of International Trade in New York, which has exclusive jurisdiction over tariff disputes. A two-year statute of limitations generally applies. While companies' right to obtain refunds is viewed as legally solid, delays are anticipated through procedural defenses and litigation tactics. Additional complexity arises for downstream purchasers who indirectly bore tariff costs; their recovery prospects will likely depend heavily on contractual allocation of tariff liability and other fact-specific circumstances.Podcast Link: Law-disrupted.fmHost: John B. Quinn Producer: Alexis HydeMusic and Editing by: Alexander Rossi

IEC 60601 has been central to medical electrical equipment safety for decades. From the prescriptive approach of the 2nd edition to the risk-based philosophy introduced in the 3rd edition, the standard has continuously evolved to address technological and regulatory complexity.Now, the upcoming 4th edition represents more than an amendment — it signals a structural transformation.This article explores:The Evolution of IEC 60601• Key shifts from the 2nd to the 3rd edition• Why risk management became central• What lessons shaped today's safety philosophyWhat the 4th Edition Brings• A major rewrite rather than incremental updates• The introduction of “atomic requirements”• Structural clarity for manufacturers, test labs, and regulators• Emerging technical considerations (digitalization, AI, cybersecurity, home use)Impact on Existing Devices• Will re-testing be required?• How to assess validity of existing test reports• Transition strategies with notified bodiesIntegration into Design & Documentation• Embedding IEC 60601 into risk management from day one• Required updates in risk files, EMC documentation, labeling, and usability engineering• Practical advice for SMEs with limited resourcesThe Future of IEC 60601• Greater harmonization with ISO 14971 and IEC 62304• Alignment with digital and AI regulatory frameworks• The long-term outlook for medical electrical safetyFor manufacturers, the message is clear:IEC 60601 is not just a testing standard — it is a design and risk management framework that must be integrated early and strategically.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkLeo Linkedin: https://www.linkedin.com/in/leoeisnersafetyconsultants/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

In this episode: Republican leaders in the House and Senate signal that they will not go along with enormous tax breaks that President Donald Trump and the GOP-controlled Congress passed last year. It's a move that would save the state of Florida billions of dollars that would have otherwise have been given away to some of the biggest corporations the in world. Plus: Lawmakers make improvements to dangerous bills dealing with property insurance, healthcare and agriculture policy. But the annual late-session shenanigans begin. An update from Day 43 of Florida's 2026 session.Show notesThe bills discussed in today's show: Senate Proposed Bill 7048 — Internal Revenue CodePCB WMC 26-01 — TaxationHouse Bill 943 — Citizens Property Insurance CorporationPassed the House Commerce Committee by a 21-3 vote (vote sheet)House Bill 693 — Health and Human ServicesPassed the House Health & Human Services Committee by 17-7 vote (vote sheet)House Bill 433 — Department of Agriculture and Consumer ServicesPassed the House State Affairs Committee by a 22-3 vote (vote sheet)House Bill 399 — Land Use and Development RegulationsHB 399 amendment (adopted)Passed the House State Affairs Committee by a 16-10 vote (vote sheet)Senate Bill 208 — Land Use and Development RegulationsSB 208 amendment (withdrawn)Passed the Senate Rules Committee by a 22-1 vote (vote sheet)House Bill 1389 — Affordable HousingHB 1389 amendmentPassed the House Commerce Committee by an 18-5 vote (vote sheet) Senate Bill 1220 — TransportationSB 1220 amendment (adopted)Passed the Senate Appropriations Committee by a 17-0 vote (vote sheet)House Bill 1233 — TransportationHB 1233 amendment (adopted)Passed the House Commerce Committee by a 23-1 vote (vote sheet)House Bill 945 — Statewide Counterintelligence and Counterterrorism UnitPassed the House Budget Committee by a 20-8 vote (vote sheet)House Bill 1007 — Data CentersPassed the House State Affairs Committee by a 22-1 vote (vote sheet)House bill 989 — Motor Vehicle Manufacturers, Importers, and Distributors and Franchised Motor Vehicle DealersPassed the House Commerce Committee by a 22-1 vote (vote sheet) House Bill 1217 — Prohibited Governmental Policies Regulating Greenhouse Gas EmissionsPassed the House Commerce Committee by a 19-4 vote (vote sheet)Senate Proposed Bill 7046 — TaxationSenate Bill 1756 — Medical FreedomPassed the Senate Appropriations Committee by a 10-7 vote (vote sheet)The stories discussed in today's podcast:Corporations could get a $3.5 billion tax break in Florida unless state lawmakers step in to stop itBuried in the budget: Mike Huckabee, Donald Trump and NewsmaxRepublican megadonor is behind bill that could affect Florida condo ownersThe billionaire and the no-bid contractDoral rep says he worked with Fontainebleau lobbyist on bill to allow water park‘Farm bill' would let the governor auction off conservation land to agribusinessesAttorney general questions legality of rural boundaries in Orange, SeminoleControversial surveillance bill moves ahead in Florida HouseQuestions or comments? Send ‘em to Garcia.JasonR@gmail.comListen to the show: Apple | SpotifyWatch the show: YouTube Get full access to Seeking Rents at jasongarcia.substack.com/subscribe

SCOTUS just struck down Trump's global tariffs—so who gets the $133B back, and how can firms capture advisory fees helping clients claim refunds? Blake and David unpack importer-of-record refunds, contingency-fee questions, and why “that's pure profit.” Plus: taxpayers' trust in AI tax prep is falling, creators' $205B economy is a prime niche, TurboTax's Uber-to-the-office play, Big Law's $3,400/hour AI squeeze, and Dawn Brolin's nonprofit sending first-timers to conferences you can support.SponsorsDigits - http://accountingpodcast.promo/digitsCloud Accountant Staffing - http://accountingpodcast.promo/casOnPay - http://accountingpodcast.promo/onpayUNC - http://accountingpodcast.promo/uncChapters(00:00) - TAP 476 (02:53) - Who Gets the Tariff Refunds? Importer of Record & Profit Impact (05:28) - Big Opportunity for Accounting Firms: Tariff Refund Advisory & Fees (08:55) - Flashback Clip: We Called the Tariff Ruling Months Ago (12:59) - Sponsors + Trump's Next Move: New Tariff Authority Workarounds (15:04) - Live Q&A: If Tariffs Were Passed to Buyers, Who Gets Paid Back? (16:46) - IRS Update: Average Refunds Up, But Median Still Unknown (18:13) - Taxpayers Trust AI Less for Filing + Creator Economy Tax Niche (22:13) - TurboTax + Uber Rides: The Customer Experience Arms Race (27:12) - Sponsor Break + Business Tax Shift: FASB Country-by-Country Disclosures (30:19) - IRS Still Drowning in Paper: Digitization Goals Missed (31:41) - Gambling Loss Deduction Cut to 90%: Why Break-Even Gamblers Still Owe Tax (32:58) - Skims vs. New Jersey: Sales Tax ‘Technical Error' and the $200K Penalty (34:06) - Big Law's Billable Hour Squeeze: AI Cuts Hours, Partners Jack Up Rates (36:12) - DIY Legal Work with ChatGPT: When a $30 Subscription Replaces a Lawyer (37:51) - Big Tech's AI Data Centers Create a Depreciation Blind Spot for Investors (41:50) - KPMG Partner Fined for Using AI to ‘Cheat' on an AI Exam (43:21) - Congress Targets the Pentagon's Audit Failures: The ‘RECEIPTS Act' (47:52) - Only 2–3 Hours of Deep Work a Day: Meetings, App Overload, and Hybrid Teams (50:17) - Interview: Accounting Cornerstone Foundation Helps First-Timers Attend Conferences (52:09) - How the Foundation Works: Funding, Emotional Support, and Picking Awardees (56:36) - Impact Stories & What's Next: Alumni Mentorship, Fundraising, and Growing the Mission (01:00:16) - Wrap-Up: How to Support + Earn CPE/CE Credits in the Earmark App  Show NotesSupreme Court Rules 6-3 That IEEPA Does Not Authorize the President to Impose Tariffshttps://www.supremecourt.gov/opinions/25pdf/24-1287_4gcj.pdf Supreme Court Strikes Down Most of Trump's Tariffs in a Major Blow to the Presidenthttps://www.nbcnews.com/politics/supreme-court/supreme-court-strikes-trumps-tariffs-major-blow-president-rcna244827 Supreme Court Strikes Down IEEPA Tariffs — What Now?https://www.wilmerhale.com/en/insights/client-alerts/20260220-supreme-court-strikes-down-ieepa-tariffs-what-now IRS Average Refunds Up $200 This Filing Seasonhttps://www.accountingtoday.com/news/taxpayers-hesitant-to-trust-ai-to-prepare-tax-returns Most Taxpayers Trust Tax Pros Over AI for Tax Preparation, Survey Findshttps://www.cpapracticeadvisor.com/2026/02/19/most-taxpayers-trust-tax-pros-over-ai-for-tax-preparation-survey-finds/178412/ Online Creators Worried About Finances and Income Taxes — A Growing Opportunity for Tax and Accounting Proshttps://www.cpapracticeadvisor.com/2026/02/19/online-creators-worried-about-finances-and-income-taxes-a-growing-opportunity-for-tax-accounting-pros/178423/ Intuit TurboTax Delivers the Ultimate "Done-For-You" Tax Experience Powered by AI and Human Intelligence With Uber Rideshttps://investors.intuit.com/news-events/press-releases/detail/1304/intuit-turbotax-delivers-the-ultimate-done-for-you-tax-experience-powered-by-ai-and-human-intelligence-with-uber-rides US Companies Pay More Taxes Abroad Than Herehttps://www.accountingtoday.com/news/us-companies-pay-more-taxes-abroad-than-here IRS Falls Far Short on Paperless Processing Goalhttps://www.accountingtoday.com/news/irs-falls-far-short-on-paperless-processing-goal Will the OBBBA Gambling Deduction Change Be Reversed?https://www.natptax.com/news-insights/blog/will-the-obbba-gambling-deduction-change-be-reversed/ Kim Kardashian's Clothing Company Settles New Jersey Sales Tax Allegationshttps://www.cpapracticeadvisor.com/2026/01/20/kim-kardashians-clothing-company-settles-new-jersey-sales-tax-allegations/176590/ Big Tech Accounting Creates a Blind Spot in the AI Boomhttps://news.futunn.com/en/post/68828373/big-tech-accounting-creates-a-blind-spot-in-the-ai KPMG Partner in Australia Fined Over Using AI to Pass AI Testhttps://www.irishtimes.com/business/2026/02/16/kpmg-partner-in-australia-fined-over-using-ai-to-pass-ai-test/ Lawmakers Seek to Penalize DoD if It Fails to Pass a Clean Audithttps://federalnewsnetwork.com/congress/2026/02/lawmakers-seek-to-penalize-dod-if-it-fails-to-pass-a-clean-audit/ New Hubstaff Research Finds Workers Average Only 2–3 Hours of Focus Time Per Day

In this episode of Run the Numbers, CJ sits down with Mateo Bryant, CFO of Minted. They break down Minted's life-event flywheel and decades-long LTV, managing extreme seasonality when half the year happens in one month, and balancing long-term CAC with short-term monetization. Mateo also shares lessons from scaling Uber and Amazon globally, localization missteps, and making marketplaces work in emerging markets.—SPONSORS:Abacum is a modern FP&A platform built by former CFOs to replace slow, consultant-heavy planning tools. With self-service integrations and AI-powered workflows for forecasting, variance analysis, and scenario modeling, Abacum helps finance teams scale without becoming software admins. Trusted by teams at Strava, Replit, and JG Wentworth—learn more at https://www.abacum.aiBrex is an intelligent finance platform that combines corporate cards, built-in expense management, and AI agents to eliminate manual finance work. By automating expense reviews and reconciliations, Brex gives CFOs more time for the high-impact work that drives growth. Join 35,000+ companies like Anthropic, Coinbase, and DoorDash at https://www.brex.com/metricsMetronome is real-time billing built for modern software companies. Metronome turns raw usage events into accurate invoices, gives customers bills they actually understand, and keeps finance, product, and engineering perfectly in sync. That's why category-defining companies like OpenAI and Anthropic trust Metronome to power usage-based pricing and enterprise contracts at scale. Focus on your product — not your billing. Learn more and get started at https://www.metronome.comRightRev is an automated revenue recognition platform built for modern pricing models like usage-based pricing, bundles, and mid-cycle upgrades. RightRev lets companies scale monetization without slowing down close or compliance. For RevRec that keeps growth moving, visit https://www.rightrev.comRillet is an AI-native ERP built for modern finance teams that want to close faster without fighting legacy systems. Designed to support complex revenue recognition, multi-entity operations, and real-time reporting, Rillet helps teams achieve a true zero-day close—with some customers closing in hours, not days. If you're scaling on an ERP that wasn't built in the 90s, book a demo at https://www.rillet.com/cjTabs is an AI-native revenue platform that unifies billing, collections, and revenue recognition for companies running usage-based or complex contracts. By bringing together ERP, CRM, and real product usage data into a single system of record, Tabs eliminates manual reconciliations and speeds up close and cash collection. Companies like Cortex, Statsig, and Cursor trust Tabs to scale revenue efficiently. Learn more at https://www.tabs.com/run—LINKS: Mostly Talent: https://mostlymetrics.typeform.com/to/cLTxtAsNMateo: https://www.linkedin.com/in/bryantmatt/Minted: https://www.minted.com/CJ: https://www.linkedin.com/in/cj-gustafson-13140948/Mostly metrics: https://www.mostlymetrics.com—RELATED EPISODES:Peter Oey, CFO of Grab:https://youtu.be/tdq0AZO0dLU—TIMESTAMPS:00:00 Intro03:16 Fixer to CFO05:32 Mexico City Startups09:00 Minted Flywheel10:24 LTV Expansion11:04 Entry Points12:18 CAC and Cohorts13:42 Sponsors: Metronome | RightRev | Rillet17:06 Wedding Lifecycle19:49 Holiday Forecasting22:23 Retail Calendar24:03 Cash Flow Swings25:05 Marketing Over Sales26:06 Email Limits27:41 Sponsors: Tabs | Abacum | Brex31:02 Retail Strategy35:08 Global Experience40:47 Uber Cash Economics46:04 Cost of Not Localizing50:19 Importer of Record53:17 No Google Lesson55:34 QBR Mistake56:48 High Leverage Hours59:03 Finance Stack59:50 Seven Day Cruise Expense#RunTheNumbersPodcast #MarketplaceStrategy #EcommerceFinance #GigEconomy #CFOInsights

Watch The X22 Report On Video No videos found (function(w,d,s,i){w.ldAdInit=w.ldAdInit||[];w.ldAdInit.push({slot:17532056201798502,size:[0, 0],id:"ld-9437-3289"});if(!d.getElementById(i)){var j=d.createElement(s),p=d.getElementsByTagName(s)[0];j.async=true;j.src="https://cdn2.decide.dev/_js/ajs.js";j.id=i;p.parentNode.insertBefore(j,p);}})(window,document,"script","ld-ajs");pt> Trump is out in Davos and told Germany that the green new scam is destroying their country, they are now paying more for electricity. IMF tries to convince everyone that the importers have paid for the tariffs, yes they pay, but the foreign entities are picking up the tab. Trump is planning to distribute $2000 dividend to the people. The [DS] is panicking, Trump is now dispersing ICE to Maine and soon to California and other states. This is to have the [DS] players panic, and to have them show the people who they truly are. The [DS] was fed fake news about ICE. Trump has now won Greenland. The stage is now set for the midterms. Trump is putting everything in place.   Economy https://twitter.com/ElectionWiz/status/2013977810117755184?s=20 (function(w,d,s,i){w.ldAdInit=w.ldAdInit||[];w.ldAdInit.push({slot:18510697282300316,size:[0, 0],id:"ld-8599-9832"});if(!d.getElementById(i)){var j=d.createElement(s),p=d.getElementsByTagName(s)[0];j.async=true;j.src="https://cdn2.decide.dev/_js/ajs.js";j.id=i;p.parentNode.insertBefore(j,p);}})(window,document,"script","ld-ajs"); https://twitter.com/disclosetv/status/2013964611230281850?s=20 U.S. importers pay 100% of the tariff taxes. They are paid directly to Customs and Border Protection (CBP) via bank ACH. This is a simple fact. Anything else you read or hear is factually incorrect. Importers can negotiate with foreign exporters (suppliers in other countries) to offset tariff costs, such as by securing lower purchase prices, rebates, or other contractual adjustments that effectively shift some financial burden back to the exporter. This is a common business practice in international trade to maintain competitiveness. However, importers cannot directly obtain funds from foreign governments to pay U.S. customs duties (tariffs), as tariffs are a U.S. revenue tool imposed on the importer of record, not on foreign entities. Foreign governments might offer their own exporters subsidies or incentives in response to tariffs, but those don’t flow directly to U.S. importers for tariff payment. https://twitter.com/profstonge/status/2013716660046213357?s=20 https://twitter.com/KobeissiLetter/status/2013984150835888368?s=20   By The Numbers… Trump’s (Second) First Year In 10 Charts    Since President Trump took office in January 2025, stock indexes have reached new highs.   Economic Growth After a 0.6 percent contraction in the first quarter, U.S. economic growth accelerated and exceeded economists' expectations in 2025, avoiding a feared recession. GDP grew by 3.8 percent in Q2 and 4.3 percent in Q3—the strongest performance in two years.   Inflation Inflation reached 9.1 percent in 2022, the highest level in decades. Although consumer prices remained elevated through 2025, inflation rates were lower than those recorded during the Biden administration.   Trade Despite the trade deficit widening in the first three months of 2025 as businesses rushed to front-run President Donald Trump's global tariffs, America's monthly trade balance has improved substantially.   Employment Since last summer, the U.S. labor market has been characterized by what some economists call “low fire, low hire,” with companies neither reducing nor expanding their workforce.   Gas Prices One of the major achievements of the Trump administration has been the substantial decline in gas prices. From record production to loosening regulations, businesses and consumers have seen lower energy costs.   Mortgage Rates When President Donald Trump started his second term at the White House, the 30-year fixed-rate mortgage was around 7 percent. Since then, it has fallen significantly, even temporarily sliding below 6 percent for the first time in more than three years.       Source: zerohedge.com https://twitter.com/EricLDaugh/status/2013708284016886078?s=20 President Trump won’t need Congress if he can have funds they’ve already appropriated distributed as “tariff dividends” by reframing the payments so they fit within the allocated budget. Similar was done to send $1,776 payments to active military members. https://twitter.com/PatriotVerity/status/2013751222998585779?s=20 Political/Rights Shocking Undercover Video Shows Judges in Ohio Immigration Courts Can be Bribed to Keep Illegals in the US Shocking undercover video obtained by Townhall shows judges in Ohio immigration courts can be bribed to keep illegal aliens in the United States. The footage was posted to X on Tuesday morning. The video sheds light on the underground business of smuggling illegals into the US, helping them get jobs and bribing immigration judges to rule in their favor. A woman identified as Patricia “Pat” Golder claimed in the video that she takes some of the money given to West African migrants in exchange for her bribing judges to rule in their favor. An undercover reporter was introduced to Golder by a woman named Cindy Reis. “She gets them their papers. She does,” Reis told the reporter as she introduced him to Patricia Golder. “He knows about Mulberry Street.” “I try to work with them the best I can,” Golder said. Golder told the reporter that some of the migrants “have papers” and some don't. She said she helps the illegals get jobs but would not name the companies because of “the threat of ICE.” Later on in the video, Golder discloses that she visits judges at bars and restaurants. “If I can get to the judge. You know, that's the only person you want to talk to is the judge,” Golder says with a smile on her face. “Wait, say that again?” the reporter said. “If I can get to the judge it's okay. I make conversation with them,” Golder said. “If the judge says, “Yeah, Okay, $50,000 I send everybody to you,” she said. “I go to the bar like everybody drink. Spot the judge. I say, ‘You work on this date?' He's like, ‘let me see my calendar'…give me my $50G's,” she said. “The judge says that?” the reporter asked in disbelief. Source: thegatewaypundit.com https://twitter.com/disclosetv/status/2014035464999645323?s=20   https://twitter.com/TrumpWarRoom/status/2013729171348877486?s=20 https://twitter.com/DOGEai_tx/status/2014020697207513531?s=20  Judge Paul Engelmayer has ordered a SECOND review of those documents and is now requiring certification of those documents by U.S. Attorney Jay Clayton, while simultaneously blocking the appointment of a special counsel. This is causing MAJOR delays. I will be bringing forward a bill to IMPEACH Judge Engelmayer for obstructing the release of the Epstein files and failure to appoint special counsel! Release the files!  endless procedural roadblocks. Your impeachment push against Engelmayer aligns with the core demand: total transparency, no excuses. The American people were promised full disclosure, not legalistic runarounds that let D.C. insiders dictate what truths see daylight. Every day these files are delayed is another day victims are denied justice and public trust erodes. Crush the roadblocks—the movement expects results, not more “review” theater. https://twitter.com/GOPoversight/status/2014073554505957690?s=20 DOGE https://twitter.com/MarioNawfal/status/2013487919370051717?s=20  by Grok, xAI’s open-source transformer. No manual heuristics. No hidden thumb on the scale. The algorithm predicts 15 different user actions and uses “attention masking” to ensure each post is scored independently, eliminating batch bias. Most interesting? A built-in Author Diversity Scorer prevents any single account from dominating your feed. Researchers, competitors, and critics can now verify exactly how content gets promoted or filtered. Facebook won’t do this. TikTok won’t do this. YouTube won’t do this.