Podcasts about importers

A stunning streak of wins is emerging for President Trump and it's terrifying Democrats — Supreme Court currently upholds mail-in ballot restrictions, 200,000 foreigners to have their visas revoked, ICE scores major win in federal court over activist judges blocking deportation, ICE carries out historic deportation operation in Virginia-Maryland…  [X] SB – ICE arrests in MD and VA …Ilhan Omar now has an active ICE investigation into her, a $103K fine is coming on H1B visas, Hormuz oil is approaching pre-war flows in recent days…and more  Midterms fast approaching and Trump's MAGA war chest is opening. [X] SB – Pres Trump on buying beef from Argentina Trump is helping a friend. Argentina before Milei: decades of economic self-sabotage Argentina wasn't a poor country that suddenly discovered poverty. It was once one of the world's wealthiest economies. The long-term problem was a political-economic model that repeatedly combined huge government spending, deficits, monetary financing, price and currency controls, protectionism, subsidies, and increasingly heavy regulation. By the time Javier Milei won in November 2023, the accumulated damage was extraordinary: Inflation had moved into triple-digit territory.  The government was running large fiscal deficits.  Foreign-exchange reserves were depleted.  Argentina had multiple exchange rates and extensive currency controls.  The central bank's balance sheet had deteriorated badly.  Importers were accumulating commercial debt because dollars weren't available.  Real wages had collapsed.  Poverty had climbed above 45%.  Argentina was already deeply entangled with the IMF.  The IMF's description of the situation inherited by Milei is unusually blunt: "dangerously acute" imbalances and distortions, resulting from inconsistent and expansionary policies.  That's the environment in which Milei's message of burn down the economic establishment resonated. He wasn't elected because Argentines suddenly became libertarian philosophers. They had lived through enough economic dysfunction that the political equivalent of throwing a brick through the window started looking attractive. What Milei actually did Milei came in December 2023 and immediately attacked the core problem: government spending and monetary disorder. His government imposed severe fiscal discipline, reduced subsidies and spending, deregulated portions of the economy, loosened trade restrictions and foreign-exchange controls, and pursued monetary stabilization. And, importantly, it hurt initially. But the macroeconomic results have been striking. Kevin Jackson has been called, the "white-collar" Joe Rogan. Given their similar backgrounds in TV, comedy, and martial arts, it's easy to see why people enjoy Kevin's show so much. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Host: Lalo Solorzano and Andy Shiles Guest(s): Ken Roberts and Tatiana Panzardi Published: August 13, 2026 Length: ~35 minutes Presented by: Global Training Center Summary The latest U.S. trade numbers are in—and they reveal an economy being reshaped by artificial intelligence, tariffs, changing supply chains, and new patterns in global commerce. In this quarterly trade update, Lalo Solorzano and Andy Shiles welcome back trade-data expert Ken Roberts, joined by Tatiana Panzardi of WorldCity, to unpack U.S. Census Bureau trade data through the first six months of 2026. The numbers tell a fascinating story. U.S. trade is up, Mexico is firmly positioned as the nation's leading trading partner, and Port Laredo has returned to the top among U.S. trade gateways by value. But perhaps the biggest shift is happening in technology: computer imports have surged as companies pour billions into AI infrastructure and data centers, changing rankings that were historically dominated by oil and automobiles. At the same time, passenger-vehicle imports and exports are feeling the effects of tariffs and changing automotive policy. Beyond the statistics, this episode asks the question that matters to trade professionals and business leaders: What do these numbers mean for your sourcing, markets, contracts, and growth strategy? Main Topic / Discussion U.S. trade is undergoing a structural shift. Ken and Tatiana walk through the latest trade data and explain how AI investment, tariffs, energy, automotive trade, and supply-chain realignment are changing which commodities, countries, and ports dominate U.S. commerce. One of the clearest signals is the extraordinary growth in computer imports. Through the first six months of 2026, the episode reports computer imports at approximately $194.4 billion, compared with roughly $101.4 billion during the same period in 2025. Much of that growth is tied to servers and infrastructure supporting AI data centers. Meanwhile, Mexico remains central to U.S. trade, while Taiwan, Vietnam, South Korea, and other Asian economies are becoming increasingly important within changing global supply chains. The automotive story looks different. Passenger-vehicle imports have declined amid tariffs, while exports to several major markets have also weakened. The discussion explores what that means for specialized automotive ports and for companies navigating higher costs and shifting demand. Ultimately, the hosts bring the data back to business strategy: understanding trade trends can help companies identify new export markets, rethink sourcing, anticipate supply-chain changes, and spot opportunities before competitors do. Key Takeaways • AI is rewriting the U.S. import rankings. Massive investment in servers and data-center infrastructure has pushed computers ahead of categories such as passenger vehicles and oil, illustrating how quickly AI investment is affecting physical trade flows. • Mexico's importance continues to grow. Mexico ranks as the leading U.S. trade partner in the data discussed, including its critical role in both imports and exports, while Port Laredo has again become the nation's leading trade gateway by value. • Supply chains continue shifting away from China. Taiwan, Vietnam, South Korea, and other Asian markets are taking increasingly prominent positions as tariffs, technology investment, and sourcing strategies reshape longstanding trade patterns. • Trade data should be a business-development tool. Importers, exporters, executives, and small-business owners can use commodity, country, and port data to identify growing markets, sourcing opportunities, emerging demand, and potential risks. Resources & Mentions • Global Training Center • USTradeNumbers • Ken Roberts on Forbes Credits Host: Lalo Solorzano Andy Shiles Guest(s): Ken Roberts - LinkedIn Tatiana Panzardi - LinkedIn Producer: Lalo Solorzano

Having an ISO 13485 Quality Management System in place does not automatically mean that your quality processes are effective.A strong QMS should help an organization identify problems, evaluate their significance, capture information from the market, investigate systemic issues, and continuously improve.In this Easy Medical Device podcast collection, we examine several situations that can reveal whether a QMS is truly functioning—or simply looks good on paper.Understanding NC vs CAPAOne of the most misunderstood areas of quality management is determining when to open a Nonconformity and when to escalate an issue into a CAPA.Not every isolated problem requires a complete CAPA investigation. However, when an issue becomes recurring, systemic, significant, or potentially high-risk, a deeper investigation may be necessary.The objective isn't to create as many CAPAs as possible. It's to recognize the problems that genuinely require root cause investigation and corrective action.Why “We've Never Had a Complaint” Can Be DangerousZero complaints may sound like excellent news, but it can also raise an important question:Is your organization effectively capturing all sources of customer and post-market feedback?Potential complaints may appear through distributor communications, service reports, customer emails, returned products, training feedback, or other customer-facing channels.If this information isn't properly evaluated, the organization may miss important product performance or safety signals.The Fake QMS ProblemA Quality Management System can look excellent on paper.Procedures exist. Forms are available. CAPA processes are defined. Risk management documentation is complete.But if employees don't follow those processes in daily operations, the QMS can become disconnected from reality.That's the core of the “fake QMS” problem: the documented system and the way the company actually operates become two different systems.During an audit, this gap can quickly become visible.Building a QMS That Actually WorksAn effective QMS should be integrated into everyday operations rather than maintained only for certification or audits.Problems should be identified and evaluated appropriately. Customer feedback should feed into complaint handling and post-market activities. Significant and recurring issues should trigger investigation, and lessons learned should contribute to continuous improvement.Ultimately, the goal isn't to create a perfect-looking Quality Management System.The goal is to create a QMS that helps your organization consistently identify problems, manage risk, improve processes, and support the delivery of safe and effective medical devices.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.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.

We're finding out more about the U.S. government's legal argument as they try to avoid paying back all importers for illegal tariffs. The AP's Jennifer King reports.

On July 1, a shipment of Irwin mangoes from Tainan and black-leaf lychees from Taichung cleared customs in Manchester, marking Taiwan's first official export of these fruits to the United Kingdom for 2026. Getting the fruit from Taiwan to UK supermarket shelves was not easy. In this edition of Taiwan Talk, Sunray Fresh General Manager Kris Tang talks to Hope Ngo about the challenges the importer faced to get the fruit from Taiwan's farms onto British tables. -- Hosting provided by SoundOn

SHUKHA has served as Swarovski's official importer and partner in Israel since 1993 and was the first to introduce Swarovski fashion jewelry to the Israeli market. More than three decades later, the partnership continues through retail, digital commerce, customer service and participation in Swarovski's events. SWAROVSKI | SHUKHA City: HAIFA Address: EIN DOR 20 Website: https://shukha.online/ Phone: +972-77-962-6644 Email: customer.service@shukha.biz

Host: Cindy Allen Published: August 7, 2026 Length: ~15 min Presented by: Global Training Center Summary International trade compliance is getting more complicated—and the tools used to enforce it are getting smarter. In this week's Simply Trade update, Cindy Allen puts a trade-compliance spin on Taylor Swift's The Tortured Poets Department and breaks down a busy week of tariff changes, forced-labor developments, enforcement activity, and technology. Cindy examines new Section 232 developments affecting pharmaceuticals, solar-grade polysilicon and derivative products, along with proposed additions to existing copper, steel, and aluminum measures. The growing focus on derivative products means importers increasingly need visibility beyond the finished good, including components, raw materials, suppliers, pricing, origin, and potential exemptions. She also explores CBP's increasing reliance on AI and advanced analytics, recent duty-evasion findings, UFLPA developments, China's countermeasures, and complications surrounding IEEPA duty refunds. The bigger message for trade professionals: enforcement isn't likely to disappear. As governments gain better analytical capabilities, companies need equally strong visibility into their supply chains. Technology can help uncover risk—but experienced trade professionals still have to interpret the data and make the right compliance decisions. This Week in Trade • New Section 232 requirements affecting solar-grade polysilicon and derivative products are adding another layer of supply-chain complexity. • Commerce has proposed adding 14 products to existing Section 232 measures covering copper, steel, and aluminum. • CBP's roadmap through 2030 highlights AI, analytics, interoperability, and increasingly sophisticated enforcement capabilities. • Forced-labor enforcement, China countermeasures, duty-evasion cases, and IEEPA refund validation issues continue to create compliance challenges. Main Topic / Discussion The trade environment is moving beyond traditional questions about classification, value, and country of origin. Importers increasingly need visibility deep into their supply chains to understand the components and raw materials contained in finished products, the parties involved, applicable pricing rules, and whether exemptions apply. At the same time, CBP is becoming more sophisticated in how it identifies risk. Advanced analytics can connect activity across suppliers and transactions that an importer may not immediately see. For companies, that makes supply-chain visibility and technology increasingly important. AI can help organize and analyze enormous amounts of trade data, but technology alone isn't the answer. Trade professionals still need to evaluate the results, understand the regulatory context, and determine the actual compliance risk. Key Takeaways • Section 232 derivative-product measures mean importers may need visibility all the way down to component and raw-material levels. • CBP's growing use of AI and analytical tools makes deeper supply-chain connections easier for enforcement teams to identify. • Companies should not assume heightened enforcement will disappear with future political or leadership changes. • Trade teams should evaluate whether their existing technology provides enough visibility to identify tariff exposure, exemptions, forced-labor concerns, and supplier-level risks before regulators do. Resources & Mentions • Global Training Center • U.S. Customs and Border Protection (CBP) • Section 232 tariffs and derivative-product requirements • Uyghur Forced Labor Prevention Act (UFLPA) • CBP Office of Field Operations 2030 roadmap • Trade Force Multiplier Credits Host: Cindy Allen Guest(s): N/A Producer: Lalo Solorzano

Recorded live in Napa at the Cameo cinema, this is the story of how Kirk Parsons, of Parsons fine wines - went from the Marines to a leader in importing wines from Georgia to the United States.  You can watch this episode and hundreds of other original shows and films at sommtv.com and on our apps on all devices. 

Quality and regulatory compliance are fundamental to bringing safe and effective medical devices to market. As regulations continue to evolve and technologies become more complex, manufacturers must adopt a proactive approach to quality throughout the entire product lifecycle.This podcast collection explores key topics shaping today's medical device industry, including the FDA's transition to the Quality Management System Regulation (QMSR), effective validation and supplier management strategies, and structured approaches to managing software defects in Software as a Medical Device (SaMD).Together, these discussions highlight how strong quality systems extend beyond documentation. They emphasize the importance of risk-based thinking, supplier oversight, software quality, and continuous improvement to ensure compliance while protecting patients.Whether you're working in Quality Assurance, Regulatory Affairs, Engineering, or Product Development, these conversations offer practical insights to help strengthen your Quality Management System and prepare for the evolving regulatory landscape.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.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.

Sam Filmus started importing whiskies into the United States in the 1990's, bringing Signatory and Edradour whiskies to thirsty Americans. Over the years, his ImpEx Beverages has added brands like Kilchoman, the Glenallachie, Ardnamurchan, Nc'Nean, and M&H to the range. Five years ago, he added his own independent bottlings of world whiskies under the ImpEx Collection label, with each annual edition focusing on a specific theme. We'll talk with Sam about the impact of tariffs, his company's history, and taste a couple of his whiskies on this week's WhiskyCast In-Depth. In the news, Sazerac makes another play for Brown-Forman, and a major distributor of whiskies and other spirits enters Chapter 11 bankruptcy. 

Forced labor enforcement is re-gaining momentum with 43 new entities added to the UFLPA Entity List on top of the recently issued Section 301 tariffs. Importers should prepare for more scrutiny and enforcement.

Host: Lalo Solorzano & Andy Shiles Guest(s): Valerie Sorensen-Clark Published: July 30, 2026 Length: ~25 minutes Presented by: Global Training Center Summary What happens when a court rules that tariffs were improperly imposed—and how can importers recover the money they've already paid? In this episode of Simply Trade, hosts Lalo Solorzano and Andy Shiles welcome international trade attorney Valerie Sorensen-Clark of GDLSK. Drawing from her unique experience as former U.S. Customs and Border Protection (CBP) counsel, Valerie explains the current status of IEEPA tariff litigation and what businesses should expect as CBP processes refunds. The discussion breaks down the difference between liquidated and unliquidated entries, why those distinctions matter, and how the new CAPE refund process is being implemented. Valerie also shares behind-the-scenes insight into the legal and operational challenges CBP faces while building systems to process unprecedented tariff refunds. Whether you're an importer, customs broker, trade professional, or legal advisor, this conversation offers practical guidance on determining your eligibility, understanding the refund process, and knowing when it's time to consult customs counsel. If your company paid IEEPA tariffs, this episode provides valuable context on what comes next and how to prepare. Main Topic / Discussion The conversation focuses on the evolving legal landscape surrounding IEEPA tariffs following recent court decisions and what those rulings mean for importers seeking refunds. Valerie explains: Why the courts determined the IEEPA tariffs exceeded statutory authority. The operational rollout of CBP's CAPE refund process. The critical distinction between liquidated and unliquidated entries. Why some refunds can be processed immediately while others require additional court action. Practical steps importers should take now to determine their options. Key Takeaways • Court decisions have opened the door for many importers to recover improperly collected IEEPA tariffs. • Understanding whether an entry is liquidated or unliquidated is critical because it determines how refunds may be processed. • CBP has made significant progress implementing the CAPE refund process but continues expanding functionality for more complex entry types. • Importers with significant tariff exposure should consult an experienced customs attorney to evaluate potential recovery opportunities. Resources & Mentions • Global Training Center – https://www.globaltrainingcenter.com?utm_source=SimplyTradePodcast • GDLSK LLP - https://www.gdlsk.com/?utm_source=SimplyTradePodcast  • U.S. Customs and Border Protection (CBP) • U.S. Court of International Trade (CIT) Credits Host: Lalo Solorzano — https://www.linkedin.com/in/lalosolorzano/ Andy Shiles — https://www.linkedin.com/in/andyshiles/ Guest(s): Valerie Sorensen-Clark — https://www.linkedin.com/in/valerieannsorensen/ Producer: Lalo Solorzano — https://www.linkedin.com/in/lalosolorzano/?utm_source=SimplyTradePodcast

Even the world's biggest brands, with experienced engineering teams, mature quality systems, and substantial testing budgets, sometimes release products that end in costly recalls and serious safety incidents. In this episode of China Manufacturing Decoded, Adrian and Renaud from Sofeast examine six high-profile product failures involving Mattel, Philips, Samsung, hoverboards, Fitbit, and Peloton. Each case reveals a different lesson about supplier management, reliability testing, risk analysis, product safety, and responding effectively when problems emerge after launch. These examples show why compliance alone isn't enough, and how the right engineering and quality practices can help prevent the same mistakes. Thank you to listener David B. for this question.   Show Sections 00:00 Introduction 00:30 Why major brands still suffer product failures 01:25 Mattel's lead-paint recall and supplier control 07:20 Philips CPAP machines and degrading foam 12:06 Samsung washing machines and foreseeable misuse 15:28 Hoverboards and the risks of a product gold rush 19:25 Fitbit Ionic and responding to field failures 22:56 Peloton Tread+ and designing out safety hazards 23:38 What smaller hardware companies can learn 24:14 Risk analysis, compliance, and reliability testing   Related content Why Do Importers Need Product Reliability Testing? Using Early Field Failure Analysis to Prevent Product Disasters When and Why a Product Failure Analysis Is Required 360-Degree Product Risk Assessment Why Product Safety, Quality, and Reliability Are Tightly Linked Product Reliability Testing: 7 FAQs How to Do Product Reliability Testing Ongoing Reliability Testing: Avoid Returns, Bad Reviews, and Warranty Claims Our Contract Manufacturer Agilian's Product Safety Process Media sources for this episode: https://www.sec.gov/Archives/edgar/data/63276/000119312507168471/dex991.htm https://www.theguardian.com/business/2007/aug/15/usnews.china1 https://www.washingtonpost.com/archive/business/2007/09/05/mattel-issues-third-toy-recall-of-the-summer/d751321a-543b-4eb0-83f6-8c2f481e430c/ https://www.fda.gov/medical-devices/respiratory-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines https://www.reuters.com/business/healthcare-pharmaceuticals/philips-recalls-some-3-4-million-cpap-ventilator-machines-due-foam-part-2021-06-14/ https://www.propublica.org/article/philips-kept-warnings-about-dangerous-cpaps-secret-profits-soared https://www.cpsc.gov/content/10-Firms-Recall-More-Than-500000-Hoverboards-Due-to-Fire-Hazard-Act-Now https://www.abc.net.au/news/2016-01-07/government-raises-hoverboard-safety-concerns/7072608 https://www.theguardian.com/technology/2016/jul/06/hoverboards-mass-recall-danger-explosion-fire-hazards https://www.reuters.com/article/idUSL1N19S18R/ https://www.cpsc.gov/Recalls/2022/Fitbit-Recalls-Ionic-Smartwatches-Due-to-Burn-Hazard-One-Million-Sold-in-the-U-S https://techcrunch.com/2025/01/23/fitbit-fined-12m-over-ionic-smartwatch-burns/ https://apnews.com/article/technology-business-health-lifestyle-burns-38e1113083c7ae4142bd75086b1ab34b https://www.cpsc.gov/Recalls/2021/Peloton-Recalls-Tread-Plus-Treadmills-After-One-Child-Died-and-More-than-70-Incidents-Reported https://investor.onepeloton.com/news-releases/news-release-details/peloton-refutes-consumer-product-safety-commission-claims https://www.reuters.com/business/retail-consumer/peloton-recall-treadmills-after-reports-injuries-one-death-2021-05-05/ https://www.wired.com/story/peloton-treadmill-recall/   Get in touch with us Connect with us on LinkedIn Contact us via Sofeast's contact page Subscribe to our YouTube channel Prefer Facebook? Check us out on FB

The following article of the Logistics & Mobility industry is: “USMCA 2026: 4 Scenarios Exporters and Importers Can't Ignore” by Milton Magos, Vice President Mexico, TRAFFIX.

Importers are watching to see whether upcoming Section 301 tariffs on 16 economies will add to forced-labor duties and conflict with existing trade agreements. For more information, listen to today's Two Minutes in Trade. 

Host: Lalo Solorzano Guest(s): Ashley Arnold Length: 13:20 Presented by: Global Training Center Summary In this final installment of the Simply Trade tips run with Ashley Arnold, Lalo Solorzano and Ashley turn to a foundational question with growing consequences: who truly owns import compliance? As enforcement intensifies and importer-of-record expectations receive more attention, the conversation examines why relying entirely on a customs broker is no longer a workable compliance strategy. Ashley explains that brokers remain essential partners, but importers must understand and retain responsibility for tariff classification, customs valuation, country of origin, recordkeeping, and supply-chain visibility. The discussion also explores why foreign importers of record may face tougher vetting, how increased entry volume can expose weak processes, and why service providers need clearer accountability and a reliable paper trail. The episode moves beyond theory with practical advice: establish ownership for classification decisions, use ACE reports to review entry activity, investigate data that looks unusual, and create a recurring audit cadence instead of waiting for Customs to ask questions. The message is direct: compliance cannot be treated as a one-time setup or delegated without oversight. Importers that stay engaged, document their decisions, and work proactively with their brokers will be better positioned to identify errors early and respond confidently when scrutiny increases. Main Topic / Discussion Lalo and Ashley discuss the responsibilities attached to serving as an importer of record in a heightened enforcement environment. They explain why importers must actively oversee classification, valuation, country of origin, entry data, and recordkeeping—even when a customs broker manages the filing process. The conversation also examines increased scrutiny of foreign importers of record, the growing pressure placed on brokers and surety providers, and the importance of using ACE data to identify inconsistencies before they become larger compliance problems. Key Takeaways • Importers remain responsible for the accuracy and defensibility of their customs declarations, even when a broker files entries on their behalf. • Every importer should establish clear internal ownership for tariff classification, valuation, country-of-origin determinations, and supporting records. • ACE reports can help compliance teams identify unusual tariff numbers, unauthorized activity, entry discrepancies, and other potential risks. • Proactive, recurring audits are more effective than waiting for a Customs inquiry, payment issue, or post-entry correction deadline. Resources & Mentions • Global Training Center • CBP Automated Commercial Environment • Customs Trade Partnership Against Terrorism Credits Host: Lalo Solorzano Guest(s): Ashley Arnold

Many medical device startups assume they're audit ready because they have documented procedures, completed templates, and a Quality Management System in place.However, successful audits require much more than organized documentation.In this episode of the Medical Device Made Easy Podcast, we welcome Chiratana Pot from Enlil to discuss what true audit readiness looks like and why continuous compliance is far more effective than preparing only when an audit is scheduled.What You'll LearnWhat Is an Audit Really?Many organizations view audits as exercises designed to uncover mistakes.In reality, audits evaluate whether your Quality Management System is implemented effectively and consistently—not simply whether procedures exist.Compliance vs. Audit ReadinessBeing compliant and being audit ready are not always the same.The discussion explores how companies can move beyond documentation and demonstrate that their processes are actively followed throughout the organization.Common Startup MistakesDrawing from experience working with MedTech startups, Chiratana shares the most frequent challenges organizations encounter before their first audit, including assumptions that often lead to unexpected findings.Why Traceability MattersOne of the central themes of the episode is traceability.We examine how effective traceability connects requirements, risks, design decisions, verification activities, and documentation—making change management more efficient and strengthening overall compliance.How Enlil Supports Connected DevelopmentThe conversation concludes with an overview of Enlil's approach to connected development, explaining why integrating quality into product development from the beginning helps organizations maintain continuous audit readiness rather than relying on last-minute preparation.Key TakeawayAudit readiness is not a checklist completed before an inspection.It's the result of building a culture where quality, traceability, and compliance are embedded into everyday work.For MedTech startups, developing this mindset early can simplify audits, improve product quality, and create a stronger foundation for long-term regulatory success.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.Who is Chiratana (CP) Pot? Chiratana (CP) Pot is Senior Director of Product at Enlil, a cloud-native, AI-driven development traceability platform built for medical device and life sciences organizations. Enlil connects quality, regulatory, R&D, manufacturing, and operations teams through a unified system of record, enabling traceability, auditability, and regulatory readiness across the product lifecycle. CP works with MedTech organizations to strengthen design controls and audit readiness. He is a frequent contributor on topics including design controls, lifecycle traceability, and regulatory readiness, helping organizations move beyond documentation compliance to evidence-based product development.LinkChiratana's linkedin: https://www.linkedin.com/in/chiratana-pot/Website: https://enlil.com/Enlil's LinkedIn: https://www.linkedin.com/company/enlil-inc/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: Cindy Allen and Pete Mento Published: July 23, 2026 Length: 41:32 Presented by: Global Training Center Summary Trade enforcement is entering a new phase—and importers, customs brokers, executives, and board members may all be in the line of sight. Cindy Allen and Pete Mento unpack the Department of Justice Trade Fraud Task Force's announcement that it surpassed $1 billion in civil and criminal recoveries, penalties, forfeitures, and publicly charged losses in less than one year. They explore what that milestone signals for companies that still treat customs compliance as a back-office responsibility. The conversation moves from CBP Forms 28 and 29 to the government's expanding ability to combine entry, manifest, and supply-chain data with AI-driven analysis. Cindy and Pete debate whether targeting intelligence should be shared with customs brokers and importers, how companies should approach data collaboration, and why “we've always done it this way” is becoming an increasingly dangerous compliance strategy. They also examine the USMCA annual review cycle, possible changes involving regional value content and Chinese-origin inputs, forced-labor enforcement, manufacturing policy, and the consumer behavior shaping global sourcing. Along the way, a Piggly Wiggly shame board, Bob Newhart's apartment, and the toilet-paper aisle become memorable lessons about accountability, consumption, and the true cost of inexpensive goods. This Week in Trade • The DOJ Trade Fraud Task Force surpasses $1 billion in recoveries and charged losses • Cindy's read on the growing significance of CBP Form 29 Notices of Action • AI, anomaly detection, and government supply-chain mapping • The USMCA annual review cycle and potential changes to regional content rules Main Topic / Discussion This episode explores the transition from trade facilitation and informed compliance to a far more aggressive enforcement environment. Enforcement and accountability Cindy and Pete discuss the potential exposure facing importers, customs brokers, executives, CEOs, and board members. Compliance decisions that were once treated as operational details may now create civil, criminal, financial, and reputational consequences. Data, AI, and early warning The hosts examine how CBP can use entry, manifest, supplier, and historical data to identify anomalies. They debate whether the government should share more targeting intelligence so customs brokers and importers can identify problems before an entry is filed. USMCA, sourcing, and consumers The discussion expands to the USMCA annual review process, possible Chinese-content restrictions, regional value content calculations, forced-labor enforcement, domestic manufacturing, and whether American consumers are prepared to accept higher prices or fewer choices in exchange for more ethical and regionalized supply chains. Key Takeaways • Trade compliance is no longer solely the responsibility of the customs or logistics department; executives and board members need visibility into material customs risks and compliance decisions. • CBP Forms 28 and 29 should be treated as warning signals that may justify a broader review of products, suppliers, valuation, classification, origin, and previous entries. • Importers and brokers should use data proactively to identify anomalies, understand enforcement patterns, map deeper-tier suppliers, and address risk before filing. • The USMCA review process, forced-labor enforcement, and possible changes to regional content requirements could reshape sourcing and manufacturing decisions throughout North America. Resources & Mentions • Global Training Center • DOJ: Trade Fraud Task Force Surpasses $1 Billion in Recoveries and Charged Losses • CBP Form 28 — Request for Information • CBP ACE Portal Guidance for Forms 28 and 29 • USTR: Statement on the 2026 USMCA Joint Review Credits Host: Cindy Allen Pete Mento Producer: Mara Marquez

In this episode, Scott Friedman, VP of Government Affairs at Altana, joins Madelyn to trace his journey from crafting trade enforcement policy in government to building the technology that underpins it. He explains how trade has shifted from an era of assumed free trade to being a deliberate tool of state power, highlighting rapid changes in U.S. policy, the gap between policymakers' ambitions and what regulators and companies can practically execute, and the crucial role of modern data and technology. Scott outlines Altana's vision for a trusted, transparent global trade network, including product passports as a “global entry for goods” and a federated data architecture that enables collaboration without sacrificing privacy. He contrasts Western transparency-driven systems with China's state-directed, opaque but highly efficient digital trade ecosystem, and explores evolving U.S.–EU alignment on customs, traceability, and digital infrastructure. The key takeaway: full end-to-end traceability is fast becoming the baseline expectation, and companies that lean into data-driven transparency now will be far better positioned in an increasingly complex enforcement environment. Highlights from their conversation include: Scott's Journey from Government to Trade Tech (0:41) America Founded on a Customs Dispute and Boston Tea Party (2:47) How Today's Trade Enforcement Differs from Past Eras (4:54) Gap between Policymakers, Regulators, and Global Trade (7:46) Altana Overview and Vision for Trusted Global Trade (11:22) Product Passports as Global Entry for Goods (14:08) Why Altana Uses a Federated Network Model (19:06) China's State-Directed Supply Chain Architecture (22:19) U.S. and EU Alignment on Customs, Data, and Traceability (29:29) What End-to-End Traceability Now Means for Importers (34:37) Key Takeaways and Episode Wrap-Up (39:14) Dynamo Ventures is a venture firm backing founders upgrading the physical economy. As intelligence moves into critical infrastructure and technology collides with physics, industry is entering a new era of transformation - the industrial renaissance. Born from the dirt and grit of supply chains and shaped by operations, not spreadsheets, Dynamo focuses on the complex realities of building in the real world. We invest in companies transforming infrastructure, manufacturing, logistics, transportation, and the systems that power global commerce. Dynamo works closely with founders who combine ambition with a bias to action, bringing a builder mindset to venture capital through deep operational insight, systematic pressure-testing and hands-on partnership. Our purpose is simple: to back the relentless shaping the industrial renaissance. Learn more at www.dynamo.vc. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Host: Lalo Solorzano and Andy Shiles Guest(s): Mollie Sitkowski Published: July 22, 2026 Length: 20:54 Presented by: Global Training Center Summary A rarely used provision of the Tariff Act of 1930 is suddenly at the center of North American trade. In this timely episode, Lalo Solorzano and Andy Shiles welcome customs and international trade attorney Mollie Sitkowski to unpack the administration's three Section 338 proclamations targeting specified Canadian goods. The measures announce additional 50% duties beginning August 19, 2026, across tariff lines connected to disputes involving alcoholic beverages, dairy, and motor vehicles. Mollie explains why the product coverage is broader, and more complicated, than the three headline sectors suggest, how the new duties interact with Section 232 tariffs, and why USMCA qualification does not exempt covered imports. The conversation also explores whether Congress or the courts could intervene, the possibility that the tariffs are intended to bring Canada back to the negotiating table, and the implications for deeply integrated automotive supply chains. Most importantly, the episode gives importers a practical response plan: review HTS classifications, recheck Canadian origin under 19 CFR Part 102, monitor CBP implementation guidance, model a 50% worst-case scenario, and coordinate immediately across compliance, sourcing, finance, legal, and government affairs. Whether the duties take effect as announced or change through negotiation, this is the preparation window companies cannot afford to waste. Main Topic / Discussion This episode examines the newly announced Section 338 tariffs on specified Canadian imports and what companies should do before the August 19 effective date. Mollie breaks down the legal authority, covered product categories, USMCA and Section 232 treatment, potential challenges, negotiation dynamics, and the immediate classification, origin, forecasting, and supply-chain work importers should begin. Key Takeaways • The additional 50% duty applies to specified HTS provisions, not automatically to every Canadian-origin product. • USMCA qualification does not exempt covered goods, while articles already subject to Section 232 duties are excluded from the new Section 338 duties. • Importers should validate tariff classifications and country-of-origin determinations, including the application of 19 CFR Part 102, and closely monitor CBP CSMS guidance. • Compliance, finance, sourcing, legal, customs brokers, and government affairs teams should jointly model the 50% worst-case impact and identify affected shipments, suppliers, contracts, and customers now. Resources & Mentions • Global Training Center • White House Fact Sheet: Additional Tariffs on Canada • Section 338 Proclamation: Alcoholic Beverages • Section 338 Proclamation: Dairy • Section 338 Proclamation: Motor Vehicles • Mollie Sitkowski – Faegre Drinker Credits Host: Lalo Solorzano Andy Shiles Guest(s): Mollie Sitkowski - LinkedIn Producer: Lalo Solorzano

Advertising SponsorThis episode is brought to you by Arcadia Green Coffee, Colombian coffee exporters taking fresh green coffee from Colombia to the world, farm to roastery, direct. New office now open in the UK.Instagram: https://www.instagram.com/arcadiagreencoffee/WhatsApp: https://wa.me/353877871523Episode DescriptionThis is episode 2 of a five-part solo series of The Daily Coffee Pro Podcast by Map It Forward titled Saying the Quiet Parts Out Loud.In this episode, podcast host Lee Safar addresses one of the coffee industry's most persistent open secrets: businesses routinely fail to pay their suppliers on time.Payment terms are not suggestions. When a supplier gives a café, roaster, importer or buyer seven, fourteen or thirty days to pay an invoice, that deadline forms part of the commercial agreement. But throughout the coffee supply chain, businesses frequently delay payment because they do not have enough cash available when the bill becomes due.Lee explains how this behaviour moves through the industry. Cafés delay paying roasters, milk suppliers, bakers and produce distributors. Roasters delay paying importers or producers. Importers carrying unpaid invoices may then struggle to pay exporters and farmers. One business's cash-flow problem quickly becomes somebody else's financial risk.The episode examines why this keeps happening. Many coffee businesses use most of their available capital on fit-outs, equipment, design, branding and opening expenses, then begin trading with little money left to cover ongoing operations. They expect revenue to arrive quickly, but when opening hype disappears and sales settle into reality, there may not be enough cash to pay every supplier.Some businesses then begin moving between suppliers. Once one supplier restricts their account or demands cash on delivery, the business opens an account elsewhere while leaving the original debt unpaid. This is not always driven by deliberate dishonesty, but the impact on suppliers can be severe regardless of the intention.Lee argues that the problem is rooted in fragile business models, razor-thin margins and a culture of competing through price. Businesses undercut competitors, give away equipment, chase volume and rely on future growth to compensate for work that is already unprofitable.The result is an industry built like a city of houses of cards. Rising coffee prices, labour costs, rent, logistics, foreign exchange pressure and declining consumer purchasing power are now shaking those businesses at the same time.When a café eventually closes, the consequences do not end with the owner. Employees may lose their jobs and wages without warning. Suppliers may never recover what they are owed. Roasters lose customers, importers lose volume and producers lose future demand.This episode is not about shaming business owners who are struggling. It is a warning about what happens when businesses open without enough operating capital, price irresponsibly and treat suppliers as an involuntary source of finance.Lee encourages struggling owners to confront the situation early, seek a responsible recovery plan and, where recovery is no longer possible, close with dignity rather than transferring the cost of failure to employees and suppliers.Connect with Lee Safar here:https://www.linkedin.com/in/leesafar/ https://www.instagram.com/leesafar If you found this episode valuable, make sure you're subscribed to the podcast and follow along for the rest of this 5-part series. ***************************************About Map It Forward The Daily Coffee Pro is produced by Map It Forward, supporting coffee professionals globally across the supply chain.Website: https://mapitforward.coffeeMailing list: https://mapitforward.coffee/mailinglistPatreon: https://www.patreon.com/mapitforwardInstagram: https://www.instagram.com/mapitforward.coffee/Contact: support@mapitforward.org

Advertising SponsorThis episode is brought to you by Arcadia Green Coffee, Colombian coffee exporters taking fresh green coffee from Colombia to the world, farm to roastery, direct. New office now open in the UK.Instagram: https://www.instagram.com/arcadiagreencoffee/WhatsApp: https://wa.me/353877871523Episode DescriptionThis is episode 2 of a five-part solo series of The Daily Coffee Pro Podcast by Map It Forward titled Saying the Quiet Parts Out Loud.In this episode, podcast host Lee Safar addresses one of the coffee industry's most persistent open secrets: businesses routinely fail to pay their suppliers on time.Payment terms are not suggestions. When a supplier gives a café, roaster, importer or buyer seven, fourteen or thirty days to pay an invoice, that deadline forms part of the commercial agreement. But throughout the coffee supply chain, businesses frequently delay payment because they do not have enough cash available when the bill becomes due.Lee explains how this behaviour moves through the industry. Cafés delay paying roasters, milk suppliers, bakers and produce distributors. Roasters delay paying importers or producers. Importers carrying unpaid invoices may then struggle to pay exporters and farmers. One business's cash-flow problem quickly becomes somebody else's financial risk.The episode examines why this keeps happening. Many coffee businesses use most of their available capital on fit-outs, equipment, design, branding and opening expenses, then begin trading with little money left to cover ongoing operations. They expect revenue to arrive quickly, but when opening hype disappears and sales settle into reality, there may not be enough cash to pay every supplier.Some businesses then begin moving between suppliers. Once one supplier restricts their account or demands cash on delivery, the business opens an account elsewhere while leaving the original debt unpaid. This is not always driven by deliberate dishonesty, but the impact on suppliers can be severe regardless of the intention.Lee argues that the problem is rooted in fragile business models, razor-thin margins and a culture of competing through price. Businesses undercut competitors, give away equipment, chase volume and rely on future growth to compensate for work that is already unprofitable.The result is an industry built like a city of houses of cards. Rising coffee prices, labour costs, rent, logistics, foreign exchange pressure and declining consumer purchasing power are now shaking those businesses at the same time.When a café eventually closes, the consequences do not end with the owner. Employees may lose their jobs and wages without warning. Suppliers may never recover what they are owed. Roasters lose customers, importers lose volume and producers lose future demand.This episode is not about shaming business owners who are struggling. It is a warning about what happens when businesses open without enough operating capital, price irresponsibly and treat suppliers as an involuntary source of finance.Lee encourages struggling owners to confront the situation early, seek a responsible recovery plan and, where recovery is no longer possible, close with dignity rather than transferring the cost of failure to employees and suppliers.Connect with Lee Safar here:https://www.linkedin.com/in/leesafar/ https://www.instagram.com/leesafar If you found this episode valuable, make sure you're subscribed to the podcast and follow along for the rest of this 5-part series. ***************************************About Map It Forward The Daily Coffee Pro is produced by Map It Forward, supporting coffee professionals globally across the supply chain.Website: https://mapitforward.coffeeMailing list: https://mapitforward.coffee/mailinglistPatreon: https://www.patreon.com/mapitforwardInstagram: https://www.instagram.com/mapitforward.coffee/Contact: support@mapitforward.org

One solo episode wasn't enough to settle the debate over the world's best wine cities — so this time, two frequent flyers weigh in. Jenna Fields and Zack Musick of the German Wine Collection, who log more travel miles promoting German wine than almost anyone in the industry, join to build their own list using the same four-part framework from the last episode: selection, people, variety, and identity. London tops it (officially "Germany-adjacent"), followed by a New York walking tour through Michelin-starred dining rooms, a surprise nod to Phoenix's under-the-radar sommelier scene, and a park-bench cheesesteak in Philly washed down with Frappato from a plastic cup. Pour a glass of the Meyer-Näkel Illusion Blanc de Noir — this month's wine club pick — and settle in for round two. Featured Wine: 2023 Meyer-Nakel "Illusion" Blanc de Noirs

For many medical device startups, obtaining FDA clearance seems like a clear, linear process.Identify a predicate device.Prepare your documentation.Submit your application.Wait for clearance.In reality, the journey is rarely that simple.In this episode of the Medical Device Made Easy Podcast, Joanna Nathan, CEO of Prana Surgical, shares her firsthand experience navigating the FDA clearance process and discusses the challenges that many startups only discover after they begin.Topics CoveredThe Reality Behind FDA ClearanceWhen do founders realize the process is more complex than expected?What would they do differently if they could start again?Predicate Devices and Substantial EquivalenceChoosing the right predicate device is one of the most important strategic decisions in a 510(k) submission.We discuss:Predicate device selectionIntended use considerationsTechnological characteristicsCommon misconceptions about substantial equivalenceBuilding a Product with the FDA in MindThe conversation explores how early regulatory decisions influence:Product developmentTesting strategyDocumentationRisk managementManufacturing planningWorking with the FDAHow valuable are Pre-Submission (Q-Sub) meetings?What questions should manufacturers ask?What mistakes should they avoid before engaging with the FDA?Lessons Every Startup Should KnowJoanna shares practical advice on:Unexpected FDA questionsCommon causes of delaysSoftware validationBiocompatibilityUsability studiesDocumentation preparationThe biggest misconceptions surrounding FDA clearanceKey TakeawayFDA clearance is much more than completing regulatory paperwork.Successful companies integrate regulatory thinking into product development from the very beginning.Making the right strategic decisions early can save significant time, reduce costs, and improve the likelihood of a successful FDA submission.Whether you're launching your first medical device or preparing your next regulatory submission, this episode provides practical insights to help you navigate the FDA clearance journey with greater confidence.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.LinkJoanna's LinkedIn: https://www.linkedin.com/in/joannacnathanPrana System: https://www.pranasurgical.com/prana-systemPrana Surgical's LinkedIn: https://www.linkedin.com/company/pranasurgicalSocial 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.

For many medical device companies, a successful audit is seen as the ultimate proof that their Quality Management System is performing well.Few or no findings.Positive feedback from auditors.Management celebrates.But does passing an audit really mean your QMS is healthy?In this episode of the Medical Device Made Easy Podcast, we explore why the answer is often no.Audits Are Samples—Not Complete EvaluationsWhether it's an ISO 13485 audit, a Notified Body assessment, an FDA inspection, or an internal audit, auditors can only review a small sample of your quality system.They cannot examine every complaint, every supplier, every design decision, or every production batch.A successful audit demonstrates compliance with the sampled evidence—but it does not guarantee that every aspect of the system is functioning effectively.The "Audit Mode" ProblemMany organizations unintentionally enter "Audit Mode" before inspections.Training records are updated.CAPAs are closed.Procedures are revised.Management reviews suddenly take place.While preparation is important, organizations should ask themselves:Are we improving our QMS—or simply preparing for an audit?Culture Matters More Than FindingsSome of the most significant quality risks rarely appear during an audit.Examples include:Employees afraid to report mistakesPoor communication between departmentsWeak supplier relationshipsDesign decisions that are never challengedInformal workarounds that bypass documented proceduresThese issues can remain invisible during a short audit while gradually increasing organizational risk.Measuring the Real Health of Your QMSInstead of focusing only on audit findings, management should monitor indicators such as:Complaint investigation timelinesCAPA closure performanceSupplier management effectivenessRisk management updatesCross-functional communicationNear-miss reportingContinuous improvement initiativesThese metrics often provide a far more accurate picture of QMS maturity than the number of audit findings alone.Final ThoughtPassing an audit is an important achievement and deserves recognition.However, organizations should never confuse regulatory compliance with operational excellence.A healthy Quality Management System is not built to impress auditors.It is built to consistently deliver safe, effective, and compliant medical devices while continuously improving every day—even when no auditor is watching.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.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, Andy Shiles Guest(s): Jen Diaz Published: July 9, 2026 Length: 31:14 Presented by: Global Training Center Summary The Consumer Product Safety Commission is entering a new era of import enforcement, and importers need to pay attention. In this episode of Simply Trade, Lalo Solorzano and Andy Shiles welcome back trade attorney Jen Diaz for a timely conversation about CPSC's move into mandatory electronic filing for Certificates of Compliance. Jen breaks down what importers must understand regarding the July 8, 2026 effective date, including when products require testing, what certificates must include, and why relying on assumptions or HTS codes alone can create serious risk. From children's apparel and toys to bicycles, helmets, mattresses, rugs, furniture, jewelry, and other consumer products, the discussion makes clear that CPSC requirements can reach far beyond what many companies expect. The episode also highlights practical steps importers can take now: use CPSC's Regulatory Robot, confirm whether a Children's Product Certificate or General Certificate of Conformity is required, work with approved testing labs, and provide certificate data to brokers before entry. For companies importing regulated consumer products, this is not just another paperwork change. It is a compliance checkpoint that could determine whether goods move smoothly or get stopped at the border. Main Topic / Discussion This episode focuses on CPSC's mandatory eFiling requirement for Certificates of Compliance and what it means for importers of regulated consumer products. Jen Diaz explains how the requirement fits into a broader enforcement trend, why importers should conduct product-level compliance reviews before shipping, and how tools like CPSC's Regulatory Robot can help companies identify applicable safety rules, testing obligations, and certificate requirements. The discussion also explores potential delays, cargo holds, laboratory testing concerns, HTS flagging, broker communication, and the importance of maintaining strong records before goods arrive in the United States. Key Takeaways • CPSC eFiling becomes a major compliance requirement for importers of regulated consumer products beginning July 8, 2026. • Importers should not rely only on HTS codes; they should use the CPSC Regulatory Robot to determine whether specific products are subject to CPSC rules. • Products that may trigger CPSC requirements include children's apparel, toys, bicycles, helmets, mattresses, rugs, imitation jewelry, pacifiers, furniture, and other general consumer goods. • Importers may need either a Children's Product Certificate or a General Certificate of Conformity, depending on the product and applicable safety rules. • Certificate data should be ready before importation and provided to brokers early so it can be filed properly with the entry. • Testing labs matter. Importers should verify that required testing is performed by approved laboratories and keep strong documentation in case CPSC questions the shipment. • Compliance should happen before sales, manufacturing, and shipping—not after cargo is already on hold. Resources & Mentions • Global Training Center • CPSC Regulatory Robot: Safer Products Start Here • CPSC Guidance and HTS List for Filing Electronic Certificates • CPSC eFiling Resources Credits Host: Lalo Solorzano – LinkedIn Andy Shiles – LinkedIn Guest(s): Jen Diaz – LinkedIn Producer: Lalo Solorzano

In this episode of Five Questions, Five Answers, Birgit Matthiesen, David Hamill, James Kim, and Antonio J. Rivera break down the June 3, executive order, Strengthening Customs Enforcement — not a tariff, but potentially one of the year's most consequential trade actions for US importers.  They cover the order's expanded disclosure demands, its 90-day overhaul of the US Customs and Border Protection's (CBP) penalty-mitigation framework, and CBP's hard-edged enforcement posture — and explain why a proactive review of import processes can turn the disruption into a competitive edge in 2026. Takeaways - It is not a tariff — but Strengthening Customs Enforcement may be the year's most consequential trade action for US importers. - Executive orders carry the full force of law, and CBP “stands ready to enforce,” now treating importing as “a privilege, not a right.” - Expect to disclose far more — foreign tax and business identifiers, affiliated partners, and supply-chain and product detail (composition, grade, size). - CBP's mitigation framework gets a 90-day overhaul: a penalty floor of at least 50% for national-security violations, and no mitigation for repeat offenders. - Brokers face more audits and maximum penalties for weak due diligence or non-cooperation. - Reassess voluntary disclosures now — and review procurement, classification, and valuation to build resilience.

In Episode 90 of Trade Splaining, Ardian Mollabeqiri and Robert Skidmore are back to unpack how geopolitics, energy markets and global shipping disruptions are finding their way into the everyday economy — from oil prices and port congestion to pain au chocolat, ice cream cones and Aperol Spritzes. We start with the Strait of Hormuz, where fears of an oil price shock ran into a more complicated reality. China's role as a “swing importer,” existing oil supply gluts, demand destruction, rerouting and refinery adaptation all helped explain why markets did not quite melt down — even as the risks around energy security and logistics remain very real. Then we follow the supply chain into breakfast and dessert. Why is a pain au chocolat more expensive? Why can an ice cream cone cost $8? The answer is not one input but many — wheat, butter, cocoa, diesel, refrigeration, labour, packaging and energy all moving in uncomfortable directions at once. Globalization, it turns out, is now coming for your snack budget. This episode also features a conversation with Jan Hoffmann, Global Lead for Maritime Transport and Ports at the World Bank, on the latest Container Port Performance Index. Jan explains what the CPPI actually measures, why port rankings can get political, how rerouting through the Red Sea, Hormuz and beyond affects port performance, and why the global shipping map is changing in ways that are more about friend-shoring than near-shoring. We also get into MSC vs Maersk, port ownership, shipping line-linked terminal operators, the geopolitics of port concessions, and — naturally — Jan's ongoing haircut index and his Washington, DC kebab recommendation. Plus: Gen Z's anti-AI nostalgia, the World Cup heat dome, Bosnia's unofficial theme song, Geneva's Aperol Spritz problem, and why 320 kilos of meth is probably over the “personal use” threshold. Listen now for a trade, shipping and geopolitics episode that connects the Strait of Hormuz, China's energy leverage, port performance, global inflation and your next overpriced ice cream cone.

Victorian Automotive Chamber of Commerce chief executive Peter Jones joined Tom Elliott to discuss the news that the importer of Peugeot cars has decided it will no longer import Peugeot cars into Australia.See omnystudio.com/listener for privacy information.

A shakeup in the auto industry across the ditch could see Peugeots disappear from the New Zealand market. Their Australian importer, Inchcape, will stop selling the brand from 2027 after sales plunged 87% from their 2005 peak. The move comes as pressure from Chinese brands mounts – with more than 220,000 sales in 2025 alone. Imported Motor Vehicle Industry Association CEO Greig Epps told Mike Hosking there's commonality across distributers and businesses on both the New Zealand and Australian side of things. And, he says, we're aligning ourselves with Australia in terms of our regulatory settings, which will make the market commonplace across both countries. LISTEN ABOVE See omnystudio.com/listener for privacy information.

Host: Warrington Ellacott Guest(s): Yannick Trudel Published: June 29, 2026 Length: Approx. 21 minutes Presented by: Global Training Center Summary Canada is moving quickly on several legislative fronts that could reshape how importers, exporters, manufacturers, and distributors manage trade compliance. In this episode, Warrington Ellacott is joined by Yannick Trudel, Partner at McMillan LLP in Montreal, to unpack three bills recently tabled in Parliament: Bill C-35, Bill C-34, and Bill C-36. The main focus is Bill C-35, a proposed forced labor enforcement measure that could significantly expand the Canada Border Services Agency's powers and shift the burden of proof onto importers and owners of goods. The discussion compares Canada's approach with the U.S. UFLPA framework and highlights why supply chain documentation, supplier certifications, tariff classification consistency, and rapid response readiness are becoming more important than ever. The episode also touches on Canada's emerging digital safety and consumer data privacy proposals, including how data localization and cross-border data flow rules may create new trade tensions under USMCA. For companies trading into Canada, the message is clear: review the bills, prepare documentation, and be ready for a more enforcement-driven environment. Main Topic / Discussion This episode explores Canada's proposed shift from forced labor reporting obligations toward stronger border enforcement. Bill C-35 would introduce a more presumptive approach to forced labor risk, potentially relying on lists of countries, regions, entities, or commodities linked to forced labor. If enacted, the bill could require importers and owners to prove that goods were not produced with forced labor. Warrington and Yannick also discuss the broader compliance environment, including Canada's existing S-211 forced labor reporting obligations, the role of CBSA, potential appeal limitations under the proposed bill, and what U.S. and Mexican traders should expect when doing business with Canadian partners. The conversation closes with a look at Bills C-34 and C-36, especially the potential trade implications of consumer data protection, digital safety rules, data sovereignty, and cross-border data flows. Key Takeaways • Bill C-35 could shift the burden of proof from CBSA to importers and owners of goods. • Importers may need stronger supplier documentation, certificates, and proof of supply chain due diligence. • Canada may develop forced labor risk lists based on countries, regions, companies, or commodities. • Consistent tariff classification and customs declarations across borders will become increasingly important. • Proposed appeal limitations could make CBSA enforcement decisions harder to challenge. • Bills C-34 and C-36 may create indirect trade implications for companies operating online or handling consumer data in Canada. Resources & Mentions • Global Training Center • Canadian Association of Importers and Exporters Credits Host: Warrington Ellacott – LinkedIn Guest(s): Yannick Trudel – LinkedIn Producer: Mara Marquez

At first glance, hearing "We've never had a complaint" sounds like excellent news.No customer dissatisfaction.No product issues.No safety concerns.But for Quality and Regulatory professionals, this statement should trigger an entirely different question:How do you know?What Is a Complaint?Many organizations believe a complaint only exists when a customer submits an official complaint form or explicitly uses the word "complaint."Regulators take a much broader view.A complaint may include:Unexpected device performanceProduct malfunctionsCustomer dissatisfactionUsability issuesDistributor observationsTechnical support interactionsReturned productsAny information suggesting the device may not meet requirementsComplaints Are Often HiddenPotential complaint signals can be found in:Customer emailsDistributor communicationsService reportsSales team discussionsTraining sessionsSocial media commentsTechnical support ticketsIf these sources are ignored, valuable post-market information is lost.Why Zero Complaints Can Be a Red FlagImagine a company with:5,000 devices on the marketProducts sold in 20 countriesDaily clinical useAnd yet...No complaintsNo usability observationsNo customer questionsNo returned devicesExperienced auditors may not celebrate.Instead, they may question whether the complaint handling process is effective enough to capture real-world information.Complaint Handling Impacts the Entire Quality SystemWeak complaint collection doesn't only affect one procedure.It directly influences:Clinical Evaluation Reports (CER)Post-Market Surveillance (PMS)PMCF activitiesPSUR preparationBenefit-Risk assessmentsState-of-the-art reviewsIf complaint data is incomplete, clinical evidence may also be incomplete.Five Practical RecommendationsDefine complaints broadly.Review every customer-facing information source.Create a structured complaint screening process.Trend data regularly to identify recurring issues.Periodically challenge your system by asking:"Would an auditor agree that we've identified every potential complaint?"Final ThoughtThe next time someone proudly says,"We've never had a complaint,"don't celebrate immediately.Ask instead,"How do we know?"Because in medical devices, the absence of complaints is not always evidence that everything is working perfectly.Sometimes, it's evidence that nobody is looking.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.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: Cindy Allen Published: June 19, 2026 Length: ~15 minutes Presented by: Global Training Center Summary In this week's episode of Simply Trade: Cindy's Version, Cindy Allen explores the growing complexity facing importers, customs brokers, and compliance professionals as trade policy continues to evolve at a rapid pace. From new developments involving the EU tariff agreement and ongoing Section 301 litigation to uncertainty surrounding the administration's customs enforcement Executive Order and the future of USMCA, the trade community is being asked to navigate an increasingly complicated environment. Inspired by Taylor Swift's Labyrinth, Cindy focuses on a theme many trade professionals can relate to: finding a way through complexity when the path forward is anything but straightforward. What was once a relatively predictable customs process has become a maze of overlapping tariff programs, country-specific rules, component-level reporting requirements, trade remedies, and constantly evolving compliance obligations. The episode serves as both a trade update and a reminder that while the complexity may feel overwhelming, the trade community continues to adapt, innovate, and move forward. This Week in Trade • The European Union approved implementation of the Turnberry Tariff Deal, helping prevent additional tariff escalation between the U.S. and EU. • The Supreme Court declined to hear challenges involving Section 301 Lists 3 and 4 tariffs, leaving those tariffs in place. • President Trump threatened potential 100% tariffs on French wine and champagne related to France's digital services tax. • Questions continue surrounding implementation of the Executive Order on Strengthening Customs Enforcement, with few details yet available from CBP or other agencies. • USMCA negotiations remain ongoing, with expectations that negotiations will continue beyond the current deadline. • The Commercial Operations Advisory Committee (COAC) is scheduled to meet July 15 as industry engagement continues. Main Topic / Discussion The central focus of this episode is the increasing complexity of global trade compliance. Cindy walks through how trade professionals are now managing multiple overlapping tariff programs simultaneously. What once required understanding product classification, valuation, country of origin, and free trade agreements has evolved into a system layered with Section 301 actions, Section 122 duties, Section 232 tariffs, country-specific exceptions, company-specific provisions, component-level reporting requirements, and detailed U.S.-content calculations. This complexity extends beyond importers. Customs brokers must understand not only which tariffs apply, but also the correct order of application, reporting requirements, ACE programming impacts, and evolving CBP guidance. Meanwhile, importers are being asked to collect and maintain supply chain information at a level of detail that many organizations have never previously required. Drawing on the theme of Labyrinth, Cindy compares today's trade environment to navigating a maze where everyone—from CBP to brokers to importers—is trying to find the correct path through an increasingly complicated regulatory landscape. Key Takeaways • The EU tariff agreement provides some stability for transatlantic trade. • Section 301 tariffs continue to withstand legal challenges. • Significant uncertainty remains around implementation of the Customs Enforcement Executive Order. • USMCA negotiations are unlikely to conclude by the current deadline. • Trade compliance requirements are becoming increasingly detailed and data-driven. • Importers, brokers, software providers, and CBP are all adapting to unprecedented levels of complexity. • The ability to manage complexity may become one of the most important competitive advantages in international trade. Resources & Mentions • Global Training Center • Trade Force Multiplier • Commercial Operations Advisory Committee • USMCA Credits Host: • Cindy Allen – LinkedIn Producer: • Lalo Solorzano

One of the most common sources of confusion in medical device Quality Management Systems is knowing when to open a Nonconformity (NC) and when to initiate a Corrective and Preventive Action (CAPA).Some organizations turn every issue into a CAPA, while others rarely open one at all. Both extremes can create challenges during audits and may indicate an immature quality system.In this episode of the Medical Device Made Easy Podcast, we explain the fundamental differences between NCs and CAPAs and explore real-life situations to help quality professionals make better decisions.A Nonconformity simply indicates that a requirement has not been met. A CAPA, however, is a structured process designed to investigate and eliminate the root cause of significant, recurring, or systemic issues.Through multiple scenarios, we discuss:When an isolated event should remain a simple NC.How trends and recurring problems justify CAPAs.Why a single event can trigger a CAPA when patient safety is involved.Whether a CAPA always requires a Nonconformity first.Alternative sources of CAPAs, including complaints, audits, PMS activities, PSUR reviews, PMCF activities, and management reviews.How auditors evaluate the maturity of a CAPA system.The three questions every quality professional should ask before deciding between an NC and a CAPA.The objective is not to open more CAPAs, nor to avoid them. The objective is to open the right CAPAs, based on risk, recurrence, and impact.Understanding this distinction is essential for building a robust and effective quality management system that supports compliance, patient safety, and continuous improvement.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.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.

The logistics world is seeing average tariff rates jump by 10x! Curtis Spencer of IMS Worldwide breaks down how Foreign Trade Zones (FTZs) are no longer just a good idea, they're essential for cutting costs and building resilient supply chains. Learn about duty deferral, re-export benefits, and merchandise processing fee caps that can save your business millions. Follow the FreightWaves Today Podcast Other FreightWaves Shows Learn more about your ad choices. Visit megaphone.fm/adchoices

The logistics world is seeing average tariff rates jump by 10x! Curtis Spencer of IMS Worldwide breaks down how Foreign Trade Zones (FTZs) are no longer just a good idea, they're essential for cutting costs and building resilient supply chains. Learn about duty deferral, re-export benefits, and merchandise processing fee caps that can save your business millions. ⁠Follow the FreightWaves Today Podcast⁠ ⁠Other FreightWaves Shows⁠ Learn more about your ad choices. Visit megaphone.fm/adchoices

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 : 00:01:49 - Le 6/9 de l'été - 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

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

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:

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. Dvorak on Twitter Follow Andrew Horowitz on Twitter

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. 

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

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