Podcasts about QMS

Why do life science companies still scramble when an inspection is coming, even when their quality systems are solid on paper? Yeime Martich, a 25-year quality veteran, makes the case that readiness is a logistics and culture problem, not a documentation problem, and that the procedures you wrote may be creating more audit risk than you realize.Yeime discusses why "minimally compliant" is a discipline rather than a shortcut, how leadership shapes quality culture through what they ask about, fund, and tolerate, and why the strongest signal of a healthy quality system is when people come to quality voluntarily to report problems.A few of Yeime's key takeaways:Inspection readiness is the natural output of a healthy quality system, not something you build in the weeks before an audit"Minimally compliant" means meeting the regulatory intent without overcommitting in your procedures to things your team can't actually followQuality should come to the table with options, not just a no — release to warehouse on risk while the investigation closes, for exampleLeadership shapes culture through what they ask about, what they fund, and what they tolerateThe strongest quality culture signal: people voluntarily surfacing problems without fear of blameAI is useful for data analysis and review, but accountability for quality decisions sits with people — "AI didn't tell us" showed up in a recent FDA warning letterDesign your QMS around flexibility — rigid procedures that block product release unnecessarily are self-imposed constraints the regulation never requiredAbout Yeime MartichYeime Martich is Vice President of Quality Assurance at TerSera Therapeutics with 25 years of experience in pharmaceutical and medical device quality systems. Before TerSera, she spent over 11 years at Hospira in global compliance roles overseeing internal audit programs across international manufacturing sites, and held quality systems leadership positions at Melinta Therapeutics and Abbott.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

Send us Fan MailJoin us as Murray McConchie shares his journey of modernising a traditional family farm in south-west Scotland. In conversation with Kirsten and Robert, Murray discusses his farming system, the role diversification has played in building resilience, and how he is adapting to environmental and market challenges. From practical insights on livestock and land management to opportunities beyond the farm gate, this episode offers valuable ideas and inspiration for farmers looking to strengthen and future-proof their businesses. Plus, hear the unforgettable story of a 100th birthday celebration featuring a zipline...Here is a link to all episodes of QMS's podcast https://qmscotland.co.uk/news-media/qms-podcast

Sponsor: Medboardhttps://www.medboard.com/ EuropeEUDAMED: It's Go Time -May 28th 2026 for New Products: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1860&qid=1720686388639 https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdfBrand new Notified Body Rules -Implementation regulation 2026/977https://eur-lex.europa.eu/eli/reg_impl/2026/977/ojhttps://www.medtecheurope.org/resource-library/new-eu-rules-more-business-predictability-and-transparency-in-medtech-conformity-assessment/EU MDR IVDR Simplification Proposal - 2 trackshttps://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2025/1023/COM_COM(2025)1023_EN.pdfEMA Breakthrough Medical Devices Pilot  - Just launchedhttps://www.ema.europa.eu/en/news/new-pilot-support-development-breakthrough-medical-deviceshttps://www.ema.europa.eu/en/documents/presentation/presentation-breakthrough-medical-devices-pilot-information-sessio_en.pdfMIR form update - Update your files or links:https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en SwitzerlandSwissdamed device Registration - July 1st is cominghttps://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/produktregistrierung.htmlSwissmedic's 2026 PMS Focus Campaign - Class Iia, Iib and IIIhttps://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/schwerpunktaktionen/info-ueberpruefung-dokumentation-zur-ueberwachung-nach-inverkehrbringen.htmlUKMHRA proposes indefinite CE Mark Recognition - Poll is closedhttps://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devicesNew UK Clinical Trials Framework -Live Since April 28thhttps://www.gov.uk/government/news/launch-of-clinical-trial-reformsNew MHRA fees + Faster Incident Reporting -  Reminder to budget and update procedures.https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#feeshttps://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/vigilance-reporting-requirementsMHRA Medical Devices (Amendment) Regulations 2026 - Brand New, Your Input Neededhttps://www.gov.uk/government/news/mhra-invites-views-on-proposed-changes-to-medical-device-regulation EventsMedtech Summit - June 15-16, 2026 in Berlin, Germanyhttps://informaconnect.com/medtech-summitEuropean Medical Device Supplier Excellence Conference - June 9-11th, 2026 - Brussels, Belgiumhttps://medicaldevicesupplierexcellence.com/ InternationalUSA — FDA Launches -  AI Platform HALO and Upgrades Elsa to 4.0https://www.fda.gov/news-events/press-announcements/fda-expands-ai-capabilities-and-completes-data-platform-consolidation Canada: Two changes happening —  Mandatory Digital Submissions + New AI/ML Device Guidancehttps://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/mandatory-use-regulatory-enrolment-process-notice-to-industry.htmlhttps://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices/pre-market-guidance-machine-learning-enabled-medical-devices.pdf PodcastPodcast Nostalgia  Episode 384: AI Medical Devices: What Notified Bodies Really Look for (Camille Petri): https://podcast.easymedicaldevice.com/384-2/Episode 385: The Fake QMS Problem: Why your ISO 13485 System will fail and Audit: https://podcast.easymedicaldevice.com/385-2/Episode 386: Life after CE Marking: Why AI Medical Devices Need Continuous Monitoring (Osman El-Kouban): https://podcast.easymedicaldevice.com/386-2/Episode 387: Master UDI-DI: The New Layer many Medtech Companies don't Understand (Hussam Mostafa):  https://podcast.easymedicaldevice.com/387-2/Episode 388: Certifying LLM-Driven medical devices (Sandy Wright): https://podcast.easymedicaldevice.com/388-2/ Easy Medical DeviceConsulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/BOSS Program: Back Office ServiceseQMS: https://easymedicaldevice.com/smarteye-eqms/EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/Authorized Representative in EU, UK and SwitzerlandMarket access all over the world: https://easymedicaldevice.com/services/market-access/ This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Send us Fan MailWelcome to a brand new series of the QMS podcast and a fresh way of telling the story of Scotland's red meat sector

In this episode, Tom Fox welcomes Edye Edens about launching her Life Sciences Law Group (“Eedee Law”) after years of contracting in life sciences compliance across multiple firms. Edye explains she founded the firm to better align her practice with supporting clinical trial sites, vendors, and academia, which often lack the budgets and in-house legal resources of sponsors and CROs. She describes a multidisciplinary team model that includes non-attorney quality, TMF, regulatory, and inspection-readiness professionals with deep study-operations experience, enabling rapid, practical support at different price points, including fractional engagements and urgent FDA inspection support. Edye outlines four core client segments: independent sites/site networks, academic medical centers' research compliance functions, NCI-designated cancer centers, and vendors entering clinical trials who need guidance on Part 11, HIPAA, QMS, and vendor qualification. She discusses growing AI-related client needs, emphasizing evolving regulatory expectations and “compliance at the speed of business,” and shares how to connect via website, LinkedIn, and email. Key highlights: Building A Different Firm Indy Roots National Reach Lessons From Academic Medicine AI Vendors And Regulation Resources: Edye Edens on LinkedIn Eedee Law Tom Fox Instagram Facebook YouTube Twitter LinkedIn For more information on the use of AI in compliance programs, Tom Fox's new book, Upping Your Game, is available. You can purchase a copy of the book on Amazon.com. To learn about the intersection of Sherlock Holmes and the modern compliance professional, check out Tom's latest book, The Game is Afoot-What Sherlock Holmes Teaches About Risk, Ethics and Investigations on Amazon.com. Learn more about your ad choices. Visit megaphone.fm/adchoices

Why do audits still trigger panic even at companies with strong quality systems? Sneha Saggurthi — a quality compliance manager and lead auditor in cell therapy — breaks down the gap between being compliant and being audit ready, and shares the psychology, patterns, and logistics that actually determine inspection outcomes.Sneha discusses how auditors think and prioritize, why logistics matter more than most companies realize, and the specific psychological techniques auditors are trained to use — including how to handle them.A few of Sneha's key takeaways:Being compliant and being audit ready are not the same thing — compliance is your documentation; readiness is your logistics, your plan, and your ability to defend your approachAuditors think in terms of SISPQ (safety, identity, strength, purity, quality) — everything rolls up to whether the product has those attributesLogistics are the make or break — fast document retrieval, defined roles, and coordinated teams create more auditor confidence than perfect systems with slow accessBatch records are the most common rabbit hole — have a storyboard ready for anything you put in front of an auditorTrain your floor staff to be comfortable with auditors, not to hide from them — use internal audits as practiceAuditors use strategic silence, open-ended questions, and deliberate friendliness to get people talking — train your team to give concise answers and redirect to documentationThe daily question that changes everything: "If someone reads this two years from now, will they know what happened?"About Sneha SaggurthiSneha Saggurthi is Quality Compliance Manager at Cartesian Therapeutics, a cell therapy company, where she manages inspection readiness, supplier quality, and the audit program. She holds an ASQ Certified Quality Auditor (CQA) credential and a Lean Six Sigma Green Belt, with prior quality and training roles at Catalent, Precision For Medicine, and Charles River Laboratories. She is an adjunct instructor at Frederick Community College and serves as Vice Chair of Young Women In Bio.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

The transition from a cleared medical device to a commercialized product is one of the most perilous phases for a MedTech startup. While founders frequently anticipate the technical and regulatory hurdles of early-stage development, they often underestimate the "commercial valley of death." Success in the modern healthcare economy requires more than a functional prototype and clinical validation; it requires an exact blueprint to navigate the complex organizational structures of health systems, ambulatory surgery centers, and value analysis committees.A primary pitfall for early-stage innovators is the discrepancy between clinical data expectations and real-world market entry. Founders naturally possess an unwavering belief in their technology to secure funding, yet this can inadvertently lead to an overestimation of rapid adoption and an underestimation of institutional purchasing complexity. Mitigating this pressure requires integrating strategic commercial leadership early in the timeline—often months prior to receiving regulatory clearance—to properly align the market profile and build institutional momentum before the product officially launches.Choosing the right commercial framework depends heavily on the disruptive nature of the device itself. While traditional hiring mechanisms or independent distributors can be effective for incremental or transactional product categories, highly disruptive technologies and high-ticket capital equipment demand a deeper, more execution-focused partnership. Implementing a modern, fractional commercial model provides seed-stage companies with a capital-efficient method to engage veteran industry strategics, reassure investors, establish clear operational ROI for hospital administrators, and build a lasting culture of advocacy within clinical environments.Key Timestamps00:01 – Introduction to the Commercial Valley of Death: Etienne Nichols introduces guest Ryan O'Mahoney and redefines the "valley of death" as the treacherous phase spanning prototyping, global scaling, and institutional market adoption.03:24 – The Underestimation vs. Overestimation Trap: Analysis of why clinical data optimism can lead to inflated forecasting and a failure to anticipate the procedural gauntlet of modern hospital purchasing.04:51 – Optimal Timing for Commercial Integration: When founders should bring on commercial expertise, highlighting why a few months prior to FDA clearance is the ideal window to build momentum.07:41 – Investor and Strategic Benefits: How early commercial positioning signals stability to venture capitalists, enhances company valuations, and opens doors for strategic corporate exits.10:03 – Go-To-Market Frameworks Compared: A breakdown of traditional full-time hiring, utilizing independent consultants, and leveraging distribution networks, alongside the risks and benefits of each.13:16 – The Rise of Modern Fractional Commercial Models: Exploring the hybrid approach as a capital-preserving mechanism designed for maximum impact on initial adoption.15:06 – The Three Non-Negotiable Pillars of Adoption: Introduction of the foundational framework required to pass go: clinical superiority, technical clinician enhancement, and administrative return on investment.18:59 – Escaping Perpetual Pilot Programs: Strategies to convert early clinical interest and hospital trials into concrete, multi-million dollar purchase orders.22:30 – Navigating Value Analysis and Hospital Budgets: How to pivot the conversation from purely clinical superiority to operational and economic ROI for healthcare administration.25:27 – Recruiting and Managing High-Intellect Commercial Teams: Building an organizational culture centered around purpose, passion, and retaining the founding team as an inspirational backbone.Quotes"They underestimate the complexity of introducing the technology and actually getting it through the gauntlet of introduction to whether it's individual hospitals, health systems, ambulatory surgery centers, or even privately owned labs and institutions." — Ryan O'Mahoney"In this modern day, and the economic climate, and the power that administration has... the clinical is not enough." — Ryan O'MahoneyTakeawaysCommercial StrategyEngage Commercial Strategy Pre-Clearance: Begin structuring your commercial roadmap and refining your Ideal Customer Profile (ICP) 2 to 3 months before expected regulatory clearance to ensure your go-to-market execution launches seamlessly.Capital Allocation & FundraisingLeverage Fractional Expertise to De-Risk Valuation: Utilizing fractional commercial executives preserves vital runway while instilling institutional confidence in investors, signaling that the organization is prepared for real-world scaling.R&D & Product AlignmentPass the Three-Pillar Framework Before Scaling: Ensure your technology satisfies all three essential vectors before attempting commercial scale: measurable clinical differences for the patient, procedural advantages over the status quo for the practitioner, and clear economic return on investment for the administration.Market DevelopmentPre-Align Administration to Avoid Broken Pilots: Prevent your device from getting stuck in perpetual, non-revenue-generating clinical trials by engaging hospital administrators in virtual demonstrations early, tying the success metrics of the pilot directly to a formal budget proposal pathway.ReferencesCatalyst Ventures: The commercial acceleration and strategy firm founded by Ryan O'Mahoney, specializing in bringing paradigm-shifting medical technologies to global markets.Etienne Nichols: Connect with the host on LinkedIn via Etienne Nichols' LinkedIn Profile.MedTech 101 SectionThe Valley of Death (Commercialization)In the medical device space, engineers often look at the "valley of death" as the difficult phase of raising money to move from a prototype to regulatory submission. However, there is a second commercial valley of death. This is the period after you get your official clearance from regulatory bodies (like the FDA), where companies frequently run out of money because they cannot figure out how to navigate complex hospital networks, get approved by purchasing committees, and turn clinical interest into consistent sales revenue.Value Analysis Committee (VAC)Think of a hospital's Value Analysis Committee as a strict gatekeeper panel for the hospital's wallet. Years ago, if a doctor liked a medical tool, the hospital bought it. Today, a formal committee made up of administrators, finance staff, and doctors must review every new product. They analyze whether the device is truly better than what they already use, if it reduces hospital stay times, and if the financial cost makes sense against the hospital's annual budget.Feedback Call-to-ActionWe want to hear from you. Have you encountered the commercial valley of death in your own medical device journey? Do you have specific regulatory, commercial, or operational topics you want us to unpack in upcoming episodes?Drop us a line at podcast@greenlight.guru with your thoughts, questions, or guest recommendations. We read every email and look forward to delivering the personalized insights you need to confidently bring your innovations to life.SponsorsThis episode of the Global Medical Device Podcast is brought to you by Greenlight Guru, the only dedicated medical device success platform. Moving successfully from innovation through the commercial gauntlet requires total synchronization across your entire lifecycle. Greenlight Guru's modern Quality Management Software (QMS) ensures your documentation, design controls, and regulatory submittals remain audit-ready and airtight during pre-market development.Once cleared, seamlessly transition your clinical data collection into the real world using Greenlight Guru's Electronic Data Capture (EDC) solutions. Together, their QMS and EDC ecosystem empowers MedTech startups to de-risk their commercialization process, satisfy demanding institutional purchasing committees, and scale safely worldwide. Learn more at www.greenlight.guru.

AI is everywhere ... except the factory. What does AI-native manufacturing look like? Is it possible? Can AI agents help manufacturers produce more product at better quality?And, maybe also enable onshoring or re-shoring?In this episode, host John Koetsier sits down with Apprentice CEO and founder Angelo Stracquatanio to explore what AI-native manufacturing really means, and why traditional AI models fall short in production environments.Instead of chatbots, this new approach uses event-driven AI agents that respond to real-time manufacturing signals: alarms, equipment data, quality issues, and more. The result? Faster troubleshooting, reduced costs, and entirely new levels of automation.Angelo breaks down how their system combines:* Specialized AI models trained on real manufacturing data* Role-specific agents (for operators, quality teams, engineers, and leadership)* Workflow automation that goes far beyond simple promptsThey also dive into:* Why general-purpose AI struggles in manufacturing* How to eliminate hallucinations with guardrails and workflows* Real-world ROI: faster investigations, lower cost of goods, improved throughput* The future of adaptive factories and personalized production* Why humans remain critical, even in highly automated environmentsIf you're in manufacturing, operations, or industrial innovation, this is a deep look at how AI is actually being deployed ...and where it's headed next.This month's TechFirst sponsor is also Apprentice. Check out their AI-native solutions for manufacturing at Apprentice.io.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're discussing the FDA's recently implemented QMSR. It went into effect on February 2nd and replaced 21 CFR Part 820. The regulation incorporates ISO 13485:2016, which is expected to help align medical device regulations globally. In this podcast, we focus on what device manufacturers should be doing now and what can wait for a later time. During this conversation, the following questions are addressed:As most are already familiar with QMS and now QMSR, we'll dive deeper. Can you tell me if all sections of the QMSR listed in the QSR are required for all medical devices?Is a full QMS required to be in place in order to secure FDA clearance or approval?What about the sections of the QMSR? Are all of them equal in terms of importance? Are some sections more important than others?When do I need to have a QMS in place?What if I never intend to market my device? First, maybe provide an example of when that would be the case, and then address the first part.Should all QMS systems look the same?Are there differences with the QMSR with premarket vs. postmarket?How do you know the QMS is working? How can you be sure?What are the important takeaways from today's session?Listen to this discussion and see if you are compliant with the new QMSR. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we'll see if your ideas/inquiries/suggestions align with a future episode.Send us Fan Mail For more medtech news and information, visit https://www.mpomag.com. 

Send us Fan MailDiscover expert strategies for enhancing beef and lamb systems. Learn about nutrition, health planning, and effective transitions for livestock management.In the world of farming, especially in beef and lamb production, achieving efficiency and sustainability is more crucial than ever. With rising demand and ever-evolving challenges, farmers must adapt their practices to ensure success. In this podcast, we're joined by industry experts Lorna Shaw and Fiona Crowden, discussing animal health, nutrition, and efficient farming practices. Here's what every farmer needs to know to optimise their operations and prepare for future challenges.Here is a link to all episodes of QMS's podcast https://qmscotland.co.uk/news-media/qms-podcast

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

Plongez dans un épisode qui risque de bousculer votre vision du système documentaire… et de son vrai coût.On parle souvent de procédures, de conformité, de qualité.Mais rarement de ce que cela représente réellement pour un site industriel.Et pourtant, derrière chaque document se cache une mécanique bien plus complexe qu'il n'y paraît. Formation, temps passé, erreurs, déviations… tout s'additionne, souvent sans que personne ne s'en rende compte .Combien coûte vraiment un document ? Et surtout, pourquoi ce coût est largement sous-estimé ?Avec ces chiffres très concrets, vous allez découvrir l'envers du décor d'un système documentaire… parfois tentaculaire.Mais ce n'est pas tout. On parle aussi efficacité, accessibilité, standardisation… et des leviers pour transformer un système lourd en véritable outil de performance.Un épisode à écouter si vous voulez comprendre pourquoi votre documentation peut être à la fois indispensable… et terriblement coûteuse.Spoiler : vous ne verrez plus jamais vos procédures de la même façon. Promotion AQE 

In this episode of Let's Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. This episode walks through how to actually read it and what matters in practice.Covers: • Scope and where GMP begins • API starting material (core concept) • GMP scaling across the process (Table 1) • Quality unit and QMS expectations • Production and in-process controls • Validation and change control • CMOs and supply chain • Clinical trial flexibility (Section 19)Timestamps00:00 Intro00:13 What Q7 Covers01:23 Scope and GMP Start02:19 API Starting Material04:05 GMP Scaling (Table 1)05:30 Quality and QMS06:58 Production Controls08:26 Validation09:46 Change Control10:27 CMOs / Supply Chain12:11 Clinical13:12 Takeawayshttps://database.ich.org/sites/default/files/Q7%20Guideline.pdfSubhi Saadeh is the Founder and Principal at Let's ComBinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.

Why are there over 400 phase three oncology programs but only one in dialysis? John Butler, who has spent over 30 years in the kidney disease space, breaks down the regulatory and reimbursement dynamics that have created a surge of innovation in rare kidney diseases while leaving dialysis patients behind, and what it would take to change that.John discusses how FDA clarity on endpoints transformed the rare kidney disease investment landscape, why the dialysis bundle makes innovation functionally impossible for providers, and how the Kidney Care Access Protection Act could be the first meaningful step toward a sustainable path for new dialysis therapies.A few of John's key takeaways:Regulatory clarity is the single biggest driver of rare kidney disease investment — FDA's work with industry to define approvable endpoints changed the entire landscapeThe dialysis bundle is structurally hostile to innovation — at $280 per session for all services, supplies, and drugs, there's no room for new therapiesThe Corsuva story is a cautionary tale — a good product at a reasonable price failed because the payment mechanism didn't workK-CAPA could change the calculus by extending the TDAPA window to three years and shifting to pay-per-use reimbursementInvestors are willing to take clinical risk, but they need a clear path to both approval and paymentFDA and CMS are generally better when they don't try to coordinate — FDA should focus on science and benefit-risk, not system costThe science is moving upstream — SGLT-2s, GLP-1s, porcine kidney transplants, and wearable kidneys all point toward a future with fewer patients on dialysisAbout John ButlerJohn Butler is President and CEO of Akebia Therapeutics, where he has led the company for over 12 years. He has worked in kidney disease since 1991, with roles at Amgen and 13 years at Genzyme leading the renal and rare disease businesses. John chaired the American Kidney Fund and Kidney Care Partners, and recently testified before the House Ways & Means health subcommittee on dialysis innovation and reimbursement reform. He holds an MBA from Baruch College's Zicklin School of Business and a BA in Chemistry from Manhattan University.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

In this episode, we welcome Matthias ,Kucharska-Hulsmann CEO of Tiebreaker AI, as we explore the intersection of AI and compliance in organizations. Matthias shares his journey from technical consulting to founding Tiebreaker AI, a SaaS solution designed to help organizations navigate complex compliance landscapes. Discover how Tiebreaker AI transforms data into actionable insights, enabling companies to become audit-ready faster. Join us for a deep dive into the challenges and innovations shaping the future of compliance in high-risk environments.Chapters:(00:00) Innovation Fuel explores the real decisions behind building ventures, technologies and organizations(05:28) Tiebreaker is a SaaS solution that helps companies comply with regulations(12:10) A lot of compliance is changing especially regarding AI(13:52) Matthias: Where does the breakdown happen between information and action(14:59) Matthias: Sometimes we complain that AI is not really generating good stuff(20:18) What is your challenge to grow right now at QMS(23:51) What are you working on right now that will shape the future of Tiebreaker(26:19) We always end the show with a challenge. Do you want to throw a challenge out there to our audience(28:03) Matthias says the best way to reach tiebreaker AI is through LinkedIn

What does it actually take to navigate global regulatory filings across the FDA, EMA, and PMDA, and why do so many programs stumble despite technically harmonized dossiers? AJ Acker draws on about 30 years of rare disease regulatory experience to break down the real differences between regions and the strategies that drive successful multi-regional approvals.AJ discusses why ICH compliance doesn't equal regulatory alignment, how Japan's evolving regulatory landscape creates both opportunity and complexity, and why the preparation that starts early in development (not at submission) is what determines whether a program achieves tight global approval timelines.A few of AJ's key takeaways:FDA, EMA, and PMDA share the same goal but ask fundamentally different questions — sponsors need to understand each lens, not just the shared scienceICH harmonization provides a common foundation, but technical alignment is not regulatory alignment — region-specific engagement is essentialStart planning for all three regions early, especially Japan — PMDA will ask why they weren't included in early developmentExpect different regulators to want different endpoints from the same data — early conversations prevent study design misalignmentLocal regulatory experts and ex-regulators are most valuable as strategic advisors and early warning systems, not just document producersSimultaneous filings are becoming the norm, but resource planning for parallel review cycles is criticalAI is emerging as a tool for sharpening submission strategy — not replacing expertise, but catching gaps human reviewers might missAbout AJ AckerAJ Acker is Senior Vice President of Regulatory, Quality & Clinical Safety at Annexon Biosciences. He has about 30 years of pharmaceutical industry experience with a focus on rare diseases and global regulatory approvals across the FDA, EMA, and PMDA. Prior to Annexon, AJ led global regulatory affairs at Zogenix (including serving as President of Zogenix Japan K.K.) and held regulatory leadership roles at Bioskin, Santen, and BioMarin. He is an Oregon State University alumnus.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

Send us Fan MailThis latest podcast episode builds on the discussions from our Building Better Beef Supply Chain event, offering those who couldn't attend, or who want to revisit the key themes, the chance to hear more through practical, experience-led conversation.Bringing together an independent consultant, and working farmer, the first episode in this two part episode explores how the beef and lamb supply chain can become more resilient, efficient and future-ready, with a strong focus on real on-farm insight and lived experience.Here is a link to all episodes of QMS's podcast https://qmscotland.co.uk/news-media/qms-podcast

Bret Tollgaard from Sunrez joins to discuss UV-curing prepreg that cuts blade repair time by up to 90% and has recently received OEM approval. Sign up now for Uptime Tech News, our weekly newsletter on all things wind technology. This episode is sponsored by Weather Guard Lightning Tech. Learn more about Weather Guard’s StrikeTape Wind Turbine LPS retrofit. Follow the show on YouTube, Linkedin and visit Weather Guard on the web. And subscribe to Rosemary’s “Engineering with Rosie” YouTube channel here. Have a question we can answer on the show? Email us! Allen Hall: Brett, welcome back to the program.  Bret Tollgaard: Thanks for having me again.  Allen Hall: So a lot’s happening at sunrise at the moment. Uh, there’s, uh, activity with sunrise materials on a lot of blades this year. Over the last couple of years actually, ISPs, operators, OEMs, are realizing that UV curing is a huge advantage.  Bret Tollgaard: Turns out there’s a lot of value added, uh, to the entire process when utilizing UV cure, uh, pre-req.  Allen Hall: So the, the pre pres are, have been available for a couple of years. The qualification though was always the concern. Has the OEM qualified this material? Are they gonna give you the blessing? Does this show up in the manual? If I call the OEM, are they gonna say they have talked to you guys? A lot of those hurdles have been cleared at this point.  Bret Tollgaard: Yeah, great question. And we are happy to announce that we have finally been approved by a large OEM for use on the epoxy blade for now all general kind of repairs. We have several more OEMs that have already passed their phase one mechanical testing, and we’re iterating through now [00:01:00] their, uh, secondary and tertiary kind of tests. And so we do expect to be fully qualified by several OEMs before the end of the year, which should make the ISPs integration and utilization of our materials much, much easier. Allen Hall: So the, the, the problem you’re solving is repairs in the field for the most part, or sometimes in the factory. Mm-hmm. But a lot of times in the field that those repairs. It happened quite a bit. They’re the same repair, the same area, the same kind of thing over and over and over again. And wetting out fabric on site takes time. Particularly if you’re using standard materials, you have to bag it. You have to apply heat in some cases to get it to kick, and then you have to wait several hours for it to cure. So in the repair cycle time, most of your time is waiting.  Bret Tollgaard: It sure is. Uh, and on top of all that, we all know that there aren’t enough technicians in this industry to even do all the repairs, uh, that would like to be done. Yeah. And so to really kind of streamline all of that, [00:02:00] uh, we’ve rolled out a couple of new things and we’ve had a lot more interest in some pre consolidated preki patches for customers. Uh, if a particular blade model has an issue that is a standardized kind of repair. We’re actually now building custom prepregs, or we will build the appropriate width length, stack it, consolidate it, uh, wrap it between our films. So then all the customer has to do when they get on site is, uh, you know, do do the appropriate surface prep. Scarfing, apply a little bit of our UV surface primer to the backside of that patch. But now they can go up tower, single peel, stick, roll out, and then they’re cured.  Allen Hall: And that’s a. How many hours of saving is that? It’s gotta be like six, 12 hours of saving, of, of  Bret Tollgaard: labor. It’s upwards of 80 to 90% of the labor that’s gonna actually need to be done to apply that. Otherwise, and then same thing too. We’ve had a couple instances where we took a several day repair down to one, to two to three hours. And these are multi-meter long repairs that were fast tracked because we pre consolidated preki [00:03:00] everything. Some were in flat sheet forms, some were much longer on rolls, where you’re actually then rolling out with a team. Um, and so we’ve been able to demonstrate several times, uh, over the last 12 months, uh, the, the value that a UV cure preprint.  Allen Hall: Well, sure, because that, that would make sense. The issue about wetting out fabric in the field you just done in the back of a trailer or something, somewhere like that. Usually it is, it’s that you’re never really sure that you got the fabric wetted out. The experienced technicians always feel like, have done it enough that they get very consistent results. But as you mentioned, getting technicians is hard and, and there’s so many repairs to do. So you’re doing those wetting out composite things takes practice and skill. Just buying it, preki it, where you have control over it. And you guys sell to the military all the time. So that, and you’re, are you ass 91 qualified yet? You’re in the midst of that?  Bret Tollgaard: So we, I mean, a, we just got ISO certified, uh, at the end of last year in December. So our [00:04:00] QMS system and everything like that’s up to date, that’s huge. Another big qualification for the OEMs that want to see, you know, true quality and output.  Allen Hall: That’s it. I, if I’m gonna buy a preki patch, so, uh, uh, that would make sense to me, knowing that. There’s a lot of rigor as a quality system. So when I get out the the site and I open that package, I know what’s inside of it every single time. Bret Tollgaard: Well, and that’s just it. And like we got qualified based on the materials that we can provide and the testing that’s being done in real world situations when you’re wetting out by hand and you’re vacuum backing and you’re trying to cure. It is a little bit of an art form when you’re doing that. It is, and you might think you have a great laminate, you got void content, or you haven’t properly went out that glass ’cause humidity or the way the glass was stored or it was exposed. The sizing and the resin don’t really bite. Well. You might think you have a great repair, but you might be prematurely failing as well after X cycles and fatigue. Uh, simply because it’s not as easy to, to truly do. Right? And so having the [00:05:00] pre-wet, uh, pre impregnated glass really goes a long way for the quality, uh, and the consistency from repair to repair. Allen Hall: Well, even just the length of the season to do repairs is a huge issue. I, I know I’ve had some discussions this week about opening the season up a little bit, and some of the ISPs have said, Hey, we we’re pretty much working year round at this point. We’re, we’ll go to California. We’ll go to Southern Texas. We’ll work those situations. ’cause the weather’s decent, but with the sunrise material, the temperature doesn’t matter.  Bret Tollgaard: Correct. And I was actually just speaking to someone maybe half hour ago who came by and was talking about repairs that they had to do in Vermont, uh, in December. They could only do two layers of an epoxy repair at a time because of the amount of the temperature. Allen Hall: Yeah.  Bret Tollgaard: Whereas you could go through, apply a six or an eight layer pre-reg cure it in 20 minutes. Uh, you know, throughout that entire length that he had and you would’ve been done. That’s, and so it took several days to do a single repair that could have been done in sub one hour with our material.  Allen Hall: I know where those wind turbines are. [00:06:00] They weren’t very far from, we used to live, so I understand that temperature, once you hit about November up in Vermont, it’s over for a lot of, uh, standard epoxy materials and cures, it is just not warm enough.  Bret Tollgaard: Yeah, we, we’ve literally had repairs done with our materials at negative 20 Fahrenheit. That were supposed to be temporary repairs. They were installed four or five years ago. Uh, and they’re still active, perfectly done patches that haven’t needed to be replaced yet. So,  Allen Hall: so, because the magic ingredient is you’re adding UV to a, a chemistry where the UV kicks it off. Correct. Basically, so you’re, it’s not activated until it’s hit with uv. You hit it with uv that starts a chemical process, but it doesn’t rely on external heat. To cure  Bret Tollgaard: exactly. It, it is a true single component system, whether it’s in the liquid pre preg, the thickened, uh, the thickened putties that we sell, or even the hand lamination and effusion resin. It’s doped with a, a variety of different food initiators and packages based on the type of light that’s [00:07:00] being, uh, used to, to cure it. But it will truly stay dormant until it’s exposed to UV light. And so we’ve been able to formulate systems over the last 40 years of our company’s history that provide an incredibly long shelf life. Don’t prematurely gel, don’t prematurely, uh, you know, erode in the packaging, all those  Allen Hall: things.  Bret Tollgaard: Exactly. Like we’ve been at this for a really long time. We’ve been able to do literally decades of r and d to develop out systems. Uh, and that’s why we’ve been able to come to this market with some materials that truly just haven’t been able to be seen, uh, delivered and installed and cured the way that we can do it. Allen Hall: Well, I think that’s a huge thing, the, the shelf life.  Bret Tollgaard: Mm-hmm.  Allen Hall: You talk to a lot of. Operators, ISPs that buy materials that do have an expiration date or they gotta keep in a freezer and all those little handling things.  Bret Tollgaard: Yep.  Allen Hall: Sunrise gets rid of all of that. And because how many times have you heard of an is SP saying, oh, we had a throwaway material at the end of the season because it expired. Bret Tollgaard: Oh, tremendously  Allen Hall: amount of, hundred of thousands of dollars of material, [00:08:00] Bret Tollgaard: and I would probably even argue, say, millions of dollars over the course of the year gets, gets thrown out simply because of the expiration date. Um, we are so confident in our materials. Uh, and the distributors and stuff that we use, we can also recertify material now, most of the time it’s gonna get consumed within 12 months Sure. Going into this kind of industry.  Allen Hall: Yeah.  Bret Tollgaard: Um, but there have been several times where we’ve actually had some of that material sent back to us. We’ll test and analyze it, make sure it’s curing the way it is, give it another six months shelf, uh, service life.  Allen Hall: Sure.  Bret Tollgaard: Um, and so you’re good to go on that front  Allen Hall: too. Yeah. So if you make the spend to, to move to sun, you have time to use it.  Bret Tollgaard: Yes.  Allen Hall: So if it snows early or whatever’s going on at that site where you can’t get access anymore, you just wait till the spring comes and you’re still good with the same material. You don’t have to re-buy it.  Bret Tollgaard: Exactly. And with no special storage requirements, like you mentioned, no frozen oven or frozen freezer, excuse me, uh, or certain temperature windows that has to be stored in, uh, it allows the operators and the technicians, you know, a lot more latitude of how things actually get  Allen Hall: done. And, and so if. When we [00:09:00] think about UV materials, the, the questions always pop up, like, how thick of a laminate can you do and still illuminate with the UV light? And make sure you curate I I, because you’re showing some samples here. These are,  Bret Tollgaard: yeah.  Allen Hall: Quarter inch or more,  Bret Tollgaard: correct. So  Allen Hall: thick samples. How did you cure these? Bret Tollgaard: So that was cured with the lamp that we’ve got right here, which are standard issued light, sold a couple hundred into this space already. Um, that’s 10 layers of a thousand GSM unidirectional fiber. Whoa. This other one is, uh, 10 layers of, of a biox. 800 fiber.  Allen Hall: Okay.  Bret Tollgaard: Uh, those were cured in six minutes. So you can Six  Allen Hall: minutes. Bret Tollgaard: Six minutes.  Allen Hall: What would it take to do this in a standard epoxy form?  Bret Tollgaard: Oh, hours,  Allen Hall: eight hours maybe?  Bret Tollgaard: Yeah. About for, for the, for the post cure required to get the TGS that they need in the wind space, right? Absolutely. And so yeah, we can do that in true minutes. And it’s pre impregnated. You simply cut it to shape and you’re ready to rock. Allen Hall: And it looks great when you’re done, mean the, the surface finish is really good. I know sometimes with the epoxies, particularly if they get ’em wetted out, it doesn’t. It [00:10:00] doesn’t have that kind of like finished look to it.  Bret Tollgaard: Exactly. And the way that we provide, uh, for our standard, uh, you know, pre pprs are in between films and so if you cure with that film, you get a nice, clean, glossy surface tack free. But as more and more people go to the pre consolidation method down tower, so even if they buy our standard prereg sheets or rolls, they’re preki down tower, you can also then just apply a pre, uh, a peel ply to that top film. Oh, sure. So if you wet out a peel ply and then you build your laminate over the top. Put the primer and the black film over when they actually get that up on tower, they can then just remove that fuel ply and go straight to Sandy or uh, uh, painting and they’re ready to rock.  Allen Hall: Wow. Okay. That’s, that’s impressive. If you think about the thousands and thousands of hours you’ll save in a season. Where you could be fixing another blade, but you’re just waiting for the res, the cure,  Bret Tollgaard: and that’s just it. When you’re saving the amount of labor and the amount of time, and it’s not just one technician, it’s their entire team that is saving that time. Sure. And can move on to the next [00:11:00] repair and the next process. Allen Hall: So one of the questions I get asked all the time, like, okay, great, this UV material sounds like space, age stuff. It must cost a fortune. And the answer is no. It doesn’t cost a fortune. It’s very price competitive.  Bret Tollgaard: It, it really is. And it might be slightly more expensive cost per square foot versus you doing it with glass and resin, but you’re paying for that labor to wait for that thing to cure. And so you’re still saving 20, 30, 40 plus percent per repair. When you can do it as quickly as we can do it.  Allen Hall: So for ISPs that are out doing blade repairs, you’re actually making more money.  Bret Tollgaard: You are making more money, you are saving more money. That same group and band of technicians you have are doing more repairs in a faster amount of time. So as you are charging per repair, per blade, per turbine, whatever that might be, uh, you’re walking away with more money and you can still pass that on to the owner operators, uh, by getting their turbines up and spinning and making them more money.  Allen Hall: Right. And that’s what happens now. You see in today’s world, companies ISPs that are proposing [00:12:00] using UV materials versus standard resin systems, the standard residence systems are losing because how much extra time they’re, they’re paying for the technicians to be on site. Bret Tollgaard: Correct.  Allen Hall: So the, the industry has to move if you wanna be. Competitive at all. As an ISP, you’re gonna have to move to UV materials. You better be calling suns  Bret Tollgaard: very quickly. Well, especially as this last winter has come through, the windows that you have before, bad weather comes in on any given day, ebbs and flows and changes. But when you can get up, finish a repair, get it spinning, you might finish that work 2, 3, 4 later, uh, days later. But that turbine’s now been spinning for several days, generating money. Uh, and then you can come back up and paint and do whatever kind of cosmetic work over the top of that patch is required. Allen Hall: So what are the extra tools I need to use Sunz in the kits. Do I need a light?  Bret Tollgaard: Not a whole lot. You’re gonna need yourself a light. Okay. You’re gonna need yourself a standard three to six inch, uh, bubble buster roller to actually compact and consolidate. Sure. Uh, that’s really all you need. There’s no vacuum lights. And you sell the lights. We do, we, [00:13:00] we sell the lights. Um, our distributors also sell the lights, fiberglass and comp one. Uh, so they’re sourced and available, uh, okay. Domestically, but we sell worldwide too. And so, uh, we can handle you wherever you are in the world that you wanna start using uv, uh, materials. And yeah, we have some standardized, uh, glass, but at the same time, we can pre-reg up to a 50 inch wide roll. Okay, so then it really becomes the limiting factor of how wide, how heavy, uh, of a lamette does a, a technician in the field want to handle?  Allen Hall: Yeah, sure. Okay. In terms of safety, with UV light, you’re gonna be wearing UV glasses,  Bret Tollgaard: some standard safety glasses that are tinted for UV protection. So they’ll  Allen Hall: look yellow,  Bret Tollgaard: they’ll look a little yellow. They’ve got the shaded gray ones. Sunglasses, honestly do the same.  Allen Hall: Yeah.  Bret Tollgaard: But with a traditional PPE, the technicians would be wearing a tower anyways. Safety glasses, a pair of gloves. You’re good to go. If you’re doing confined space, work on the inside of a, a, a blade, uh, the biggest value now to this generation of material that are getting qualified. No VOC non [00:14:00] flammable, uh, no haps. And so it’s a much safer material to actually use in those confined spaces as well as  Allen Hall: well ship  Bret Tollgaard: as well as ship it ships unregulated and so you can ship it. Next day air, which a lot of these customers always end. They do. I know that.  Allen Hall: Yeah.  Bret Tollgaard: Um, so next day air, uh, you know, there’s no extra hazmat or dangerous goods shipping for there. Uh, and same thing with storage conditions. You don’t need a, a flammable cabinet to actually store the material in.  Allen Hall: Yeah.  Bret Tollgaard: Um, so it really opens you up for a lot more opportunities.  Allen Hall: I just solves all kinds of problems.  Bret Tollgaard: It, it really does. And that’s the big value that, you know, the UV materials can provide. Allen Hall: So. I see the putty material and it comes in these little tubes, squeeze tubes. What are these putties used for?  Bret Tollgaard: So right now, the, the existing putty is really just the same exact thickened, uh, resin that’s in the pre-print.  Allen Hall: Okay.  Bret Tollgaard: And it’s worked well. It’s, it’s nice we’re kind of filling some cracks and some faring, some edges and stuff if things need to be feathered in. But we’ve [00:15:00] been working on this year that we’ll be rolling out very, very soon is a new structural putty. Okay. So we’ll actually have milled fibers in there and components that will make it a much more robust system. And so we’ve been getting more inquiries of, particularly for leading edge rehabilitation. Where Cat three, cat four, even cat five kind of damage, you need to start filling and profiling before any kind of over laminates can really be done properly. And so we’re working on, uh, rolling that out here very, very soon. Um, and so that will, I think, solve a couple of needs, um, for the wind market. Uh, and then in addition to some new products that we’re rolling out, uh, is gonna be the LEP system that we’re been working on. Uh, the rain erosion testing showed some pretty good results. But we’re buying some new equipment to make a truly void free, air free system that we’re gonna it, uh, probably submit end of April, beginning of May for the next round, that we expect to have some very, very good, uh, duration and weather ability with,  Allen Hall: because it’s all about speed,  Bret Tollgaard: it’s durability. Allen Hall: All about e  Bret Tollgaard: Exactly. And ease of use by someone in the [00:16:00] field. Yeah. Or OEMs on, you know, in the manufacturing plant. Um, there has yet, in my opinion, to be a true winner in the LEP space. That is just the right answer. And so by applying our materials with the really high abrasion resistance that we expect this to have and be as simple to do as it really appeal, stick and cure, um, we think it’s gonna be a bit of a game changer in this industry. Allen Hall: Well, all the sunrise materials, once they’re cured, are sandal  Bret Tollgaard: correct.  Allen Hall: And I think that’s one of the things about some of the other systems, I always worry about them like, alright, they can do the work today, but tomorrow I have to come back and touch it again. Do I have a problem? Well, and the sun rests stuff is at least my playing around with it has been really easy to use. It’s, it’s. Uh, things that I had seen maybe 20 years ago in the aerospace market that have they thought about using the material not only [00:17:00] in the factory, but outside the factory. How easy is it to adapt to, how easy to, to paint, to all those little nuances that come up? When you’re out working in the field and trying to do some very difficult work, uh, the sunroom material is ready to go, easy to use and checks all the boxes, all those little nuances, like it’s cold outside, it’s wet outside. Uh, it’s, it’s hot outside, right? It’s all those things that, that stop ISPs or OEMs from being super efficient. All those parameters start to get washed away. That’s the game changer and the price point is right. How do. People get a hold of you and learn about the sun rose material. Maybe they, you can buy through fiberglass or through composite one. Mm-hmm. That’s an easy way to do, just get to play with some samples. But when they want to get into some quantity work, they got a lot of blade repair. They know what they’re doing this summer or out in the fall or this winter come wintertime. How do they get [00:18:00] started? What do they do?  Bret Tollgaard: Well, one of the first things to do is they can reach us through our website. Um, we’re developing a larger and larger library now for how to videos and install procedures, um, generating SOPs that are, you know, semi, uh, industry specific. But at the same time too, it’s a relatively blanket peel and stick patch, whether it’s a wind turbine blade, a corroded tank, or a pressure pipe. Um, and so yeah, www.suns.com Okay, is gonna be a great way to do it. Uh, we’re actively building more videos to put on, uh, our YouTube channel as well. Um, and so that’s kind of gonna be the best way to reach out, uh, for us. One of the big things that we’re also pushing for, for 26 is to truly get people, uh, in this, in industry, specifically trained and comfortable using the products. At the end of the day, it’s a composite, it’s a pre impregnated sheet. It’s not difficult, but there are some tips and tricks that really make the, the use case. Uh, the install process a lot easier.  Allen Hall: Sure.  Bret Tollgaard: Uh, and so just making sure that people are, are caught up on the latest and greatest on the training techniques will [00:19:00] go a long way too. Allen Hall: Yeah. It’s only as good as the technician that applies it  Bret Tollgaard: e Exactly.  Allen Hall: Yeah. That’s great. Uh, it’s great all the things you guys are doing, you’re really changing the industry. In a positive way, making repairs faster, uh, more efficient, getting those turbines running. It’s always sad when you see turbines down with something that I know you guys could fix with sun. Uh, but it does happen, so I, I need the ISPs to reach out and start calling Sun and getting in place because the OEMs are blessing your material. ISPs that are using it are winning contracts. It’s time to make the phone call to Sun Rez. Go to the website, check out all the details there. If you wanna play with your material, get ahold of fiberglass or composite one just. Order it overnight. It’ll come overnight and you can play with it. And, and once you, once you realize what that material is, you’ll want to call Brett and get started.  Bret Tollgaard: A hundred percent appreciate the time.  Allen Hall: Yeah. Thanks Brett, for being on the podcast. I, I love talking to you guys because you have such cool material. Bret Tollgaard: Yeah, no, we’re looking, uh, forward to continuing to innovate, uh, really make this, uh, material [00:20:00] splash in this industry.

What actually changes for regulatory leaders when they move between large pharma and small biotech, and what stays the same? Tammy Sarnelli draws on over 35 years of experience across organizations of every size to break down the real differences in workload, risk tolerance, resource access, and culture.Tammy discusses how organizational silos create friction in large companies, why limited resources at small companies can actually accelerate decision-making, and how risk tolerance shapes not just strategy but the speed at which products move forward, especially in rare disease.A few of Tammy's key takeaways:Regulatory expectations are the same regardless of company size — it's the day-to-day experience and workload distribution that differSilos in large organizations restrict collaboration and can fragment how a company approaches health authority interactionsSmall companies benefit from "all-in thinking" — fewer programs mean faster alignment, but leaders must fill multiple roles simultaneouslyRisk tolerance is cultural, not organizational — when people aren't punished for good-faith decisions, they move fasterRegulatory "failure" can mean not taking a chance when you had one, especially in rare disease where patients can't waitAI is shifting medical writing from structured formatting toward strategy and interpretation — but adoption speed depends on resourcesAbout Tammy SarnelliTammy Sarnelli is Senior Vice President and Global Head of Regulatory Affairs and Clinical Quality at Amylyx Pharmaceuticals. She has over 35 years of regulatory experience spanning Biogen (27 years), Bioverativ, EMD Serono (Merck KGaA), and Amylyx, working across therapeutic areas and organization sizes with a sustained focus on rare disease. She holds a Master's degree in Public Administration from Suffolk University and a Bachelor's degree in Biology from Saint Anselm College.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

In this episode, Etienne Nichols sits down with Staci Miller, a Human Factors and UX Strategist at GenUX, to demystify the role of human factors (HF) in the medical device regulatory pathway. Staci explains that many companies mistakenly treat HF as a "box-checking" exercise late in development, leading to costly submission delays or rejections when the FDA finds the documentation fails to tell a cohesive safety story.The conversation dives deep into the technical distinctions between a Use-Related Risk Analysis (URRA) and a User Failure Mode and Effects Analysis (uFMEA). Staci provides a framework for deciding which approach fits your product, emphasizing that while large conglomerates with post-market data may lean toward uFMEAs, startups and those with novel devices should prioritize the URRA to effectively map out user interactions without the crutch of existing market data.Finally, Staci addresses one of the most persistent myths in the industry: the idea that clinical trial data can replace human factors validation. She clarifies that while the two can overlap in specific, premeditated circumstances (such as complex implants like aortic valves), they serve entirely different masters—one focused on clinical efficacy and the other on the safety of the user interface across diverse environments.Key Timestamps04:12 – The common disconnect: Integrating Human Factors into ISO 14971 risk management.06:45 – URRA vs. uFMEA: How to choose based on your post-market data and predicate device status.10:30 – The "Definition of Done": Tracking the lifecycle of HF documentation from phase zero to market release.13:15 – System errors vs. Use errors: How to identify root causes during summative studies.18:50 – The "Clinical Trial Myth": Why efficacy data is not the same as usability validation.22:10 – Design Inputs vs. Design Outputs: The "Blueprint and the House" analogy for FDA submissions.25:40 – The impact of the "Use Environment": Testing for movement in ambulances and lighting in radiology suites.Quotes"The FDA doesn't put things out there just to have a good time... If they've made human factors a requirement and you're treating it as a 'suggestion,' you're giving yourself enough rope to hang yourself." - Staci Miller"People are obsessed with the product themselves—the design outputs. But the FDA wants to see the design inputs. They want to see the blueprints of how you built that house, not just the wallpaper." - Staci MillerTakeawaysPremeditation is Key: If you intend to use clinical trial data for HF validation, it must be planned in the protocol from the start; you cannot retroactively claim clinical data satisfies usability requirements.Map User Groups Early: Distinguish clearly between primary and secondary users. Bloating user sets without explaining how or why they engage with the device complicates your risk profile.Environment Matters: Documentation must account for the physical "10,000-foot view," including noise, lighting, and motion (e.g., an ambulance), as these are often where critical use errors occur.HF is Risk Management: Human factors should not live in a silo. It must align with the scales of harm (negligible to catastrophic) defined in ISO 14971 and work in tandem with Quality and Regulatory teams.ReferencesISO 14971: The global standard for the application of risk management to medical devices.FDA Human Factors Guidance: The primary document outlining expectations for usability testing and documentation.Etienne Nichols: LinkedIn ProfileMedTech 101: URRA vs. uFMEAThink of a uFMEA (User Failure Mode and Effects Analysis) like a car manufacturer looking at an old model to see why the brakes failed in the past—it relies on known data to fix specific parts.A URRA (Use-Related Risk Analysis) is like teaching someone to drive a brand-new type of vehicle (like a spaceship) for the first time. Since you don't have "crash data" yet, you have to carefully map out every single step the pilot takes and imagine every possible way they could push the wrong button in the heat of the moment.SponsorsGreenlight Guru: This episode is brought to you by Greenlight Guru, the only quality management platform designed specifically for the medical device industry. Whether you need to manage your QMS to stay compliant with ISO 14971 or streamline your clinical data through their EDC solutions, Greenlight Guru helps you move faster with less risk.Feedback Call-to-ActionWe want to hear from you! Do you have questions about your specific regulatory pathway or a topic you'd like us to cover? We provide personalized responses to every listener who reaches out. Send your thoughts, reviews, or suggestions to podcast@greenlight.guru.

How should life science companies govern their data to meet increasingly structured regulatory submission requirements and actually get value from AI? Cary Smithson shares lessons from decades of helping organizations modernize their regulatory, quality, and R&D operations.Cary discusses why data governance has become urgent across three fronts — structured submissions, cross-functional interoperability, and AI reliability — and walks through the foundational steps companies should take, the organizational challenges they'll hit, and what measurable results look like when governance is done right.A few of Cary's key takeaways:Regulatory submissions are no longer just documents — they're structured data that demands consistent master data, controlled vocabularies, and traceable lineageStart with scope and pain points, not a boil-the-ocean exercise — pilot governance in one or two high-value use cases, then scaleData ownership belongs in the business, not IT — IT facilitates, but stewards and business owners should be accountable for their dataTools support governance but don't replace it — get the people and process foundation right before selecting platformsAI reliability depends on governed data — without standardized inputs and clear provenance, models produce unreliable or unexplainable outputsTie governance to business outcomes people are already measured on — submission cycle time, audit readiness, right-first-time metrics — or compliance won't stickAbout Cary SmithsonCary Smithson is Managing Partner and Owner of LeapAhead Solutions, Inc., where she leads a consulting practice focused on IT strategy, data governance, and business process consulting for life sciences. She leads the DIA RIM Working Group and the DIA RIM Intelligent Automation Team and co-authored the DIA RIM eBook. With experience spanning large consulting firms (Grant Thornton, PharmaLex), enterprise technology organizations (OpenText), and her own practice, Cary has served clients including Regeneron, Bristol-Myers Squibb, Johnson & Johnson, Daiichi Sankyo, Bayer, and BeiGene. She is a recognized thought leader who regularly presents at industry conferences on regulatory information management, intelligent automation, and AI adoption in life sciences.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

In this episode of The Quality Hub: Chatting with ISO Experts, host Xavier Francis sits down with Suzanne Strausser, VP of Consulting and Development at Core Business Solutions, to unpack Opportunity Management—the often-overlooked half of ISO 9001 Clause 6.1. The conversation explores why organizations tend to fixate on risk while missing chances to intentionally create value, clarifies how ISO defines “opportunity” beyond simple improvement, and explains how proactive opportunity management can transform a QMS from a compliance exercise into a strategic business tool. Suzanne shares practical insights on leadership's role, cultural mindset shifts, real-world examples, and what organizations should start doing now as ISO 9001 moves toward its 2026 update, making this episode a must-listen for quality professionals looking to drive growth, innovation, and long-term success through their management systems.   Helpful Resources: How is ISO 9001 Implemented?:  https://www.thecoresolution.com/how-is-iso-9001-implemented For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015 Contact us at 866.354.0300 or email us at info@thecoresolution.com A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting

In this episode, Etienne Nichols sits down with Edwin Lindsay, a seasoned MedTech operator and QARA leader, to discuss the systemic challenges facing the pediatric medical device market. Following a personal experience in a neonatal ward, Edwin highlights the stark reality that many pediatric treatments rely on adult devices adapted off-label, often leading to safety risks and clinical inefficiencies.The conversation delves into the "mismatch" of the pediatric market: these devices require the same rigorous regulatory and quality standards as adult products but offer significantly lower financial upside due to smaller patient populations. This creates a barrier for investors and manufacturers, leaving clinicians and nurses to "work miracles" with tools that aren't always fit for purpose.Despite these hurdles, Edwin shares an optimistic vision for the future. He discusses his initiative to build a collaborative network of experts—including regulatory consultants, testing houses, and grant writers—willing to provide pro-bono or at-cost support for pediatric startups. The goal is to create a streamlined regulatory roadmap that prioritizes patient safety without the prohibitive costs that currently stall innovation.Key Timestamps00:45 – The "Pediatric Gap": Why pediatric devices have adult-level requirements but lower ROI.03:12 – Personal Insight: Edwin's experience in the hospital and the "Guinness philosophy" of giving back.05:30 – The danger of adhesives and adapting adult materials for newborn skin.08:15 – Building a pediatric volunteer network: Testing houses and consultancies stepping up.11:40 – Regulatory Roadmaps: Navigating the age variability from premature infants to adolescents.14:50 – Off-label usage risks and the "mindset shift" required for manufacturers.18:25 – Micro-timestamp: The FDA's Humanitarian Device Exemption (HDE) and P-Sub programs.21:10 – Real-world clinical friction: Alarm fatigue and sensor sensitivity in NICU settings.25:40 – The hidden costs: Manufacturing complexity, multiple SKUs, and low-volume production.Quotes"We need to give clinicians the correct tools to work their miracles. They don't want to use products off-label; they want devices actually designed for the children they are saving." - Edwin Lindsay"If you have a pediatric project, there is a community behind you. We are breaking down the barriers of risk and cost because these babies deserve a chance." - Edwin LindsayTakeawaysRegulatory Flexibility: Utilize specific FDA pathways like the Humanitarian Device Exemption (HDE) and the Pediatric Submissions (P-Sub) program to gain early feedback and specialized guidance.Collaborative Cost-Sharing: Seek out "altruistic" partners; many testing houses and manufacturers are willing to work at-cost or under different financial models for pediatric-specific innovations.Design for Sensitivity: Pediatric innovation isn't just about miniaturizing adult tech—it requires solving unique issues like alarm fatigue and skin sensitivity (e.g., non-damaging adhesives).Workflow Integration: Engage the "head nurse" early in R&D to ensure the device fits into the high-stress environment of a pediatric ward without adding to clinical fatigue.ReferencesFDA HDE Program: A regulatory pathway for devices intended for diseases or conditions that affect small populations.Greenlight Guru: The industry-leading platform for QMS & EDC solutions, helping MedTech companies maintain...

SPONSORMedboard: https://www.medboard.com/EUROPE New Harmonization Standards -  Implementing Decision 2026/193: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193Neurosurgical implantsEN ISO 14155:2020 on clinical investigationsEN ISO 18562 series on Biocompatibility for Breathing gas pathways Germany: Transition from DMIDS to EUDAMED - March 19, 2026:https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2026-03-19-registrierung-mp.html?nn=986770EUDAMED mandatory by May 28th, 2026  High-Level Conference on Medical Devices - March 16th, 2026 - Brussels:https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_enThe conference will feature three breakout sessions focusing on:Enhanced predictability for conformity assessments: combining certainty with flexibilityClinical evidence at EU level to support the regulatory framework: the key role of Expert PanelsBreakthrough technologies for better care: turning guidance into realityTeam-NB: Letter on Cybersecurity - MDR and IVDR proposal draft version:https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdfSwitzerlandSwissmedic inspection on Importers -30 importers, 232 product samples, RESULT?:https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/smc-ueberprueft-ch-importeure-2025.pdf.download.pdf/md-schwerpunktaktion-importeure-2025_en.pdf Swissdamed Webinar - May 28th, 2026:https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/swissdamed-webinar.htmlUKUK to exempt Health Institution - Not a priority for nowhttps://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devicesTrainingTeam-NB: Training on MDR technical Documentation - For manufacturers on April 19th, 2026:https://www.team-nb.org/new-session-mdr-technical-documentation-training-for-manufacturers/EasyIFUCreate eIFU and Labels easily - Compliance to EU MDR/IVDR:Https://easyifu.comRoWNorth AmericaFDA: General Wellness devices - Guidance by the FDA:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devicesFDA: Cybersecurity in Medical Devices - QMS and Pre-market submission:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarketAPACMalaysia: Electronic Certificates issued by MDA - For FSC, Manufacturing Certificates and Export Certificateshttps://portal.mda.gov.my/index.php/announcement/1746-implementation-of-electronic-certificates-for-certificate-of-free-sale-manufacturing-certificate-and-export-certificate-issued-by-medical-device-authority-mda-malaysiaIndia: Import of IVD - Online Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NDE%3DAfricaEgypt: Database for Product Registration -Online Electronic Service: https://eservicesdata.edaegypt.gov.eg/MedicalDevicesMiddle EastSaudi Arabia: SFDA inspection of QMS requirements - Process that would be followed:https://www.sfda.gov.sa/sites/default/files/2026-01/MDS-REQ10E.pdfPodcastEpisode 372 - How to remediate a Design History File (DHF): https://podcast.easymedicaldevice.com/372-2/Episode 373 - QMSR is coming: Why FDA inspections with change completely in 2026: https://podcast.easymedicaldevice.com/373-2/Episode 374 - Validation & Supplier Management in MedTech: https://podcast.easymedicaldevice.com/374-2/ServicesConsulting support: info@easymedicaldevice.comAuthorized Representative: EO@easymedicaldevice.comSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

Send a textThis episode dives in to the wide variety of routes into a career in Scotland's red meat supply chain, giving a behind-the-scenes look at the stories, motivations, and opportunities that shape careers across the sector. With insights from three special guests reflecting different journeys into the industry, the episode also includes an update from Kate Rowell, Chair of Quality Meat Scotland, as well as market insights from our specialist Abby Tong.Here is a link to all episodes of QMS's podcast https://qmscotland.co.uk/news-media/qms-podcast

How do you build an organization that can absorb change, learn from failure, and keep patients at the center—even when the science is uncertain? Nelly Viseux shares lessons from over 20 years in biotech and a decade leading cell and gene therapy development.Nelly discusses how she structured a 100-person CMC organization at Regeneron to balance innovation with operational execution, why documenting your assumptions is critical to managing risk, and what it really takes to maintain resilience when you're literally holding patient lives in your hands.A few of Nelly's key takeaways:Resilience is adaptability—build organizations that absorb and anticipate change rather than resist itSeparate innovation from execution with intentional gates for when new approaches are ready to implementDocument your assumptions so you can revisit decisions effectively when circumstances changeFailure is a process problem, not a personal one—root cause analysis should improve systems, not assign blameData is the common language that aligns scientists, regulators, and stakeholdersEveryone is a leader in cell therapy—manufacturing and QC teams hold patient lives in their handsAbout Nelly ViseuxNelly Viseux is Vice President of Cell Therapies Development, Manufacturing, Supply & Quality at Regeneron, leading a 100-person organization supporting autologous cell therapy programs. She has over 20 years of biotechnology experience spanning large pharma (Shire, Biogen, Baxter) and startups, working across cell and gene therapies, biologics, and nanoparticles. Her accomplishments include building a Phase 1 cell therapy manufacturing facility that achieved 100% cGMP success and first IND submission within two years. She holds a Ph.D. in Biochemistry and Molecular Biology from University of Lille and is a member of the Society for Immunotherapy of Cancer and the American Society of Gene & Cell Therapy.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠⁠https://www.thefdagroup.com/

The Fold's first ever listener question's episode is coming – fill out this form to pose a question of hosts Duncan Greive and Glen Kyne. This week, Glen joins Duncan to discuss a flood of major media stories, led by breaking news: The Warehouse Group's shock decision to pause all advertising. Then they discuss the future of Mediaworks after its split from QMS, the end of a dismal era for the Washington Post's CEO Will Lewis, a new CEO for Disney and a fork in the road for Nielsen in New Zealand. Learn more about your ad choices. Visit megaphone.fm/adchoices

What does 2026 hold for the retirement village sector with reform expected to be introduced in the middle of the year. Victoria also discusses the sale of MediaWorks owner QMS to Australia's Nine Entertainment.

This episode explores the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the foundational elements required for medical device compliance. Host Etienne Nichols and guest Mike Drues discuss the philosophy of building a usable system rather than a "museum of SOPs," emphasizing that the standard list of QMS sections should be viewed as a starting point rather than an exhaustive checklist.The conversation examines the critical differences between 510(k), De Novo, and PMA pathways regarding manufacturing requirements. While a 510(k) submission may not strictly require detailed manufacturing information at the time of filing, Mike explains why companies must remain audit-ready from the moment they register their establishment with the FDA. The discussion clarifies the timing of registration and the "radar" companies enter once they become commercially active.Finally, the dialogue focuses on a "triage" approach for resource-constrained startups. By prioritizing Design Controls and Risk Management during early development, teams can remain compliant and ethical without over-investing in post-market systems, such as complaint handling, before they have a product on the market. Mike warns against the dangers of "copy-and-paste" quality systems, urging manufacturers to use professional judgment to tailor their processes to their specific technology.Key Timestamps00:00 - Introduction to QMS requirements and guest Mike Drues.03:45 - The core sections of a QMS according to the Quality System Regulation.05:12 - Why the QSR list is a starting point, not a stopping point.08:20 - Regulatory vs. Ethical vs. Economical: The three legs of the medical device stool.10:30 - Do you need a full QMS for 510(k) vs. PMA submissions?13:15 - Understanding the timing and strategy for FDA Establishment Registration.15:40 - The Triage Approach: Which QMS sections matter most during early development?19:00 - The dangers of boilerplate SOPs and non-specific quality manuals.Quotes"This is a starting point. This is not a stopping point... Use your own good judgment." — Mike Drues"The goal is not really to build a museum of SOPs; the goal is a quality management system that teams will actually use." — Etienne NicholsTakeawaysPrioritize the Big Four: During the development phase, focus your limited resources on Design Controls, Risk Management, Document Control, and Supplier Quality Management.Understand Pathway Nuances: While 510(k) submissions don't require manufacturing details, you must be fully compliant and ready for inspection once your establishment is registered and the product is launched.Avoid Boilerplate SOPs: Quality systems must be specific to your organization. Including irrelevant device types or procedures in...

Episode 8: From 3-1/2 Years Ago, QMS, Super Session, Donovan. Oh Yeh. This Is Good! January 20, 2026 Here…..have another hit…..of Fresh Air is how we start this one with Quicksilver-Dino Valenti and John Cippolina. There's one song titled “2 Songs for the Señorita”, how about some SRC? All I want for you is Love, Peace and Happiness. And I remember hearing Season of the Witch on my Craig 8 track player, written and performed by Donovan and we also have Al Kooper with Stephen Stills. There's a story about a firefall and we hear from them too. This and all the TVT episodes are downloadable and the live radio version of Tales Vinyl Tells can be heard most Wednesdays on RadioFreeNashville.org and at 103.7 and 107.1 FM at 5 Central. Thanks for listening today.  My email is talesvinyltells@gmail.com.  If you want to hear a Tales Vinyl Tells when it streams live on RadioFreeNashville.org, we do that at 5 PM central time Wednesdays. The program can also be played and downloaded anytime at podbean.com, iHeart podcasts, Player FM podcasts, Listen Notes podcasts and many other podcast places. And of course you can count on hearing the Tales on studiomillswellness.com/tales-vinyl-tells anytime. Playlist: 8.1 Fresh Air-Quicksilver Messenger Service 8.2 You Aint Goin Nowhere-Byrds 8.3 2 Songs for the Señorita-Game 8.4 Love, Peace and Happiness-Chambers Brothers 8.5 Living Aint Living-Firefall 8.6 Hall of the Mountain King-SRC 8.7 Looking for a Love-J Giels 8.8 Hissing of Summer Lawns-Joni Mitchell 8.9 Wouldn't Want to be Like You-Alan Parsons Symphonic Project 8.10,11 Season of the Witch-Donovan, Super Sessions ( Mike Bloomfield, Stephen Stills, Al Kooper)

Scaling a product from preclinical development to commercial manufacturing is one of the most complex transitions life science teams face—and one of the easiest places to lose time and momentum.In this episode of The Life Science Rundown, host Nick Capman speaks with Jackie Klecker, Executive Vice President of Quality and Development Services at Lifecore Biomedical, about how sponsors and CDMOs can build robust, phase-appropriate quality systems without over-engineering early or under-preparing later.Drawing on decades of experience across pharmaceutical drug products, medical devices, APIs, and biologics, Jackie shares practical guidance on knowledge transfer, risk management, QMS maturity, and regulatory expectations across the U.S. and EU. The conversation focuses on what actually prevents costly delays—and how disciplined communication and documentation make scaling achievable.A few key takeaways:Early quality work should be right-sized, not commercialized prematurelyDesign space, material variability, and sensitivities must be understood and documented earlyFMEA works best when it evolves with the product—not when it's treated as a one-time exerciseFDA and EU requirements can diverge in ways that materially affect submission timingClear documentation and regular, direct communication prevent avoidable delaysJackie Klecker is Executive Vice President of Quality and Development Services at Lifecore Biomedical, a fully integrated CDMO with decades of experience supporting pharmaceutical drug products, medical devices, biologics, and APIs. She has led quality systems and development programs across multiple global manufacturing sites and brings deep expertise in FDA 21 CFR 210, 211, and 820, ISO 13485, EU GMP, and ICH Q7 environments. Her background spans chemical engineering, process development, validation, risk management, and cross-functional leadership.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠⁠https://www.thefdagroup.com/

The FDA Group's Nick Capman sits down with Mike Martin, President and CEO of ISPE, for a conversation on how the pharmaceutical industry must rethink workforce development amid rapid technological and cultural change.Drawing on nearly four decades of global experience in pharmaceutical engineering, operations, and manufacturing leadership, Mike shares his perspective on why the industry is entering a new industrial era — often referred to as Pharma 4.0 — and what that means for engineers, operators, and leaders at every level.The discussion explores how automation, robotics, and AI are reshaping day-to-day work, why deep technical expertise remains critical in an AI-driven environment, and how organizations must move beyond reactive reskilling toward more intentional “pre-skilling” of future talent. Mike also reflects on the enduring importance of character, integrity, curiosity, and trust, arguing that these traits matter as much as technical competence in a highly regulated industry.Nick and Mike examine the evolving role of professional organizations like ISPE in building global communities of practice, sharing knowledge across borders, and supporting lifelong learning. The conversation also addresses how learning itself is changing — from long-form training to bite-sized, modular education — and what leaders must do to engage a new generation of professionals with different expectations around purpose, speed, and technology.Throughout the episode, Mike emphasizes a unifying theme: innovation and compliance are not opposing forces. When approached correctly, innovation strengthens quality, improves compliance, and ultimately enhances patient safety.This episode is a must-listen for anyone responsible for building teams, modernizing operations, or preparing their organization for the future of pharmaceutical manufacturing and engineering.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠https://www.thefdagroup.com/

In this episode of The Quality Hub, Chatting with ISO Experts, host Xavier Francis shares standout moments from past guests to explore how a true culture of quality—grounded in ISO 9001—can significantly boost employee engagement. The discussion explains why ISO 9001 isn't just about compliance, but about creating clarity, consistency, and support that reduce stress and help people succeed. Guests describe how involving employees in improvement work builds ownership, how recognition within a QMS-driven environment strengthens morale and retention, and how leadership and middle management together keep quality systems alive in daily operations. You'll also hear practical takes on competency-based training, overcoming resistance to change, and embedding ISO into the real rhythm of work. The episode wraps with a compelling reminder to treat employees like customers—through flexibility, continuous learning, and meaningful recognition—so organizations can build workplaces where people feel valued, engaged, and motivated to grow.   Helpful Resources: How is ISO 9001 Implemented?:  https://www.thecoresolution.com/how-is-iso-9001-implemented For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015 Contact us at 866.354.0300 or email us at info@thecoresolution.com A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting

The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere streamlining, the change is mandatory, with an effective and fully enforceable date of February 2, 2026. The episode addresses industry complacency and details critical steps manufacturers must take immediately.The episode debunks the myth that familiar quality documents like the DHF, DMR, and DHR are being eliminated. While the specific terms are removed from the regulation's language, their substance is retained and mapped to new, ISO-aligned conceptual requirements: the Device Master Record (DMR) becomes the Medical Device File (MDF), the Design History File (DHF) becomes the Design and Development File (DDP), and the Device History Record (DHR) is captured in the Batch or Lot Record. The host emphasizes that internal documents can retain the old terminology, provided a clear regulatory mapping is established.Crucially, compliance requires more than just an ISO 13485 certificate. Two major philosophical shifts must be addressed: the explicit requirement for integrating lifecycle risk management as the DNA of the entire QMS, and the loss of the audit privilege, which makes internal audit reports, supplier audit reports, and management review records inspectable regulatory evidence. Furthermore, manufacturers must comply with retained, US-specific requirements under the QMSR's prevalence rule, especially concerning mandatory record content (§ 820.35) and specific labeling and packaging controls (§ 820.45).Key Timestamps[0:50] QMSR: The biggest shakeup to US quality requirements since 1996.[2:00] Effective Date: February 2, 2026—the clock is ticking.[2:42] The Goal: Harmonization with ISO 13485:2016 to reduce redundancy for global manufacturers.[3:50] Myth 1 Busted: The FDA is eliminating the DHF, DMR, and DHR (Documentation Dissolution).[5:10] Terminology Shift: DMR > Medical Device File (MDF, ISO 13485 Clause 4.2.3).[6:30] Terminology Shift: DHF > Design and Development File (DDP, ISO 13485 Clause 7.3.10).[7:40] Terminology Shift: DHR > Batch or Lot Record (ISO 13485 Clause 7.5.1).[8:40] The Practical Takeaway: Internal naming is fine, but regulatory mapping is mandatory.[10:30] Critical Shift 1: Risk Management is the DNA of the QMS—Explicitly required across all clauses.[13:00] Critical Shift 2: Loss of the Audit Privilege—Internal audit and management review records are now inspectable.[17:00] Critical Shift 3: Retained FDA Specifications (Prevalence Rule).

Send us a textThis episode dives into the latest updates to the QMS Cattle & Sheep Assurance Scheme, what's changing, why it matters, and how it strengthens both farmer practicality and consumer trust. With insights from farmer and QMS board member Niall Jeffrey and Kathryn Kerr, Head of Brands Integrity, we explore how collaboration and clarity are shaping the next 35 years of assurance.Here is a link to all episodes of QMS's podcast https://qmscotland.co.uk/news-media/qms-podcast

Dr. Yuan Li, Director of Medical Business at DQS and a former medical device auditor with deep expertise across orthopaedic manufacturing and regulatory systems.In this episode, we discuss the sweeping regulatory transition coming to the U.S. with the introduction of the Quality Management System Regulation (QMSR), which formally aligns 21 CFR Part 820 with ISO 13485. Yuan unpacks what this shift means for U.S.-based manufacturers, why FDA is phasing out the QSR audit model and why contract manufacturers and software-based device firms are particularly vulnerable if they delay planning.We also explore the growing use of AI in QMS platforms, the pitfalls of template-driven compliance, and why “regulatory fatigue” is no excuse when patients' lives are at stake. From post-market surveillance strategies to paperless QMS migrations and the validation grey zone, Yuan offers pragmatic, deeply informed advice for those navigating FDA audits, ISO certification and international expansionTimestamps[00:02:36] Why QMSR is a Big Deal for U.S. Manufacturers[00:04:09] Key Differences Between 21 CFR 820 and ISO 13485[00:05:09] Why Companies Wait Too Long to Comply[00:07:19] Impact on Contract Manufacturers and Supply Chains[00:08:36] Do You Really Need ISO 13485 Certification?[00:10:18] AI-Generated QMS Systems: Useful or Risky?[00:11:52] Most Memorable Audit Story: Iterative Design Gone Wrong[00:14:46] How to Spot Proactive vs Reactive Post-Market Surveillance[00:17:03] Why Software Companies Struggle with The Regulatory Mindset[00:20:57] What Validation Really Means Under ISO 13485Connect with Yuan - ⁠https://www.linkedin.com/in/yuan-li-phd-3bb14013/Learn more about DQS - ⁠https://www.dqsglobal.com/en/Get in touch with Karandeep Badwal - ⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠Follow Karandeep on YouTube - ⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠Subscribe to the Podcast

The FDA Group's Nick Capman sits down with Chris Masterson, Senior Vice President of Quality and Chief Quality Officer at Tolmar, for a wide-ranging conversation about how to create and sustain a quality-centric culture that drives compliance, operational excellence, and long-term resilience in the biopharmaceutical industry. A microbiologist by training with more than 35 years of BioPharma leadership experience, Chris has led global quality organizations at Ipsen, Cubist (Merck), and now Tolmar, as well as his own consultancy. Across the U.S., Europe, and Asia, he has managed large CMO networks, established inspection-readiness programs, and led cultural change within complex, matrixed organizations.Nick and Chris explore what truly defines a quality-centric culture, how leadership and accountability shape it, and the practical, long-term steps required to sustain it.In this conversation, Chris shares insights on:What “quality culture” really means—and how to make it visible at every level of an organization.The leadership behaviors that create alignment and consistency across global teams.How to embed compliance and continuous improvement into daily operations.Managing uncertainty, pressure, and change without losing focus on the patient.Practical methods for measuring and improving quality culture over time.Why humility and transparency are non-negotiable for sustainable performance.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Auditors play a critical role in evaluating QMS performance, improving compliance, and preparing organizations for ISO certification.In this podcast episode, we explore:

In this episode of The Quality Hub: Chatting with ISO Experts, host Xavier Francis welcomes back Kate Behr, consultant at Core Business Solutions, for a deep dive into the practical tools that drive continuous improvement under ISO 9001. Together, they unpack essential concepts like the Plan-Do-Check-Act (PDCA) cycle, root cause analysis, internal audits, and corrective and preventive actions, explaining how these methods help organizations strengthen their processes and culture of quality. Kate shares expert insights on overcoming common pitfalls, engaging employees in improvement efforts, and using tools like AI to enhance quality management systems. Whether you're new to ISO or a seasoned professional, this episode offers actionable strategies to keep your QMS alive, evolving, and effective.   Helpful Resources: How is ISO 9001 Implemented?:  https://www.thecoresolution.com/how-is-iso-9001-implemented For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015 Contact us at 866.354.0300 or email us at info@thecoresolution.com A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting

The FDA Group's Nick Capman sits down with Carlos Carrillo, PhD, MSc, Senior Vice President of Regulatory Affairs & Quality Assurance at SAB Biotherapeutics. With nearly 30 years of experience across Operations, R&D, Regulatory Affairs, Quality Assurance, and Project Management, Carlos has led global regulatory strategy for small- and large-molecule programs from Phase 1 through launch. He has prepared IND/IMPD/CTA/CTR/BLA/MAA submissions across multiple regions, secured expedited designations, managed FDA and ex-US health authority meetings, and built RA/QA systems for growing biotech organizations.Carlos shares practical, experience-tested guidance on how small and mid-size biotech companies can build regulatory resilience: strengthening governance, preparing for FDA interactions, improving documentation discipline, and integrating external partners without losing control. He also breaks down how to evaluate vendors, structure joint governance, embed QA into outsourced workflows, and design audit-ready data flows that prevent institutional knowledge loss.Topics discussed include:Why early regulatory infrastructure prevents costly reworkLeadership behaviors that shape regulatory cultureHow to prepare for high-stakes FDA and ex-US health authority meetingsThe risks of “tribal knowledge” in fast-moving organizationsA structured model for evaluating and managing external partnersHow small companies can stay inspection-ready with lean teamsOne takeaway: External partners can be force multipliers or liabilities—the sponsor's structure and oversight determine which.About The FDA Group:The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations.https://www.thefdagroup.com/

In this episode of Let's Combinate, Subhi Saadeh breaks down why more engineers in pharma, medical devices, and combination products should seriously consider becoming auditors. Sparked by a question at a PDA conference: “Why don't more technical people lead audits?” This episode explores the gap between technical expertise and true audit competency.Subhi explains how engineers who combine their technical background with audit training often become the most effective auditors. They gain a system-level perspective, understand how design decisions ripple through the QMS, and can identify systemic root causes that others overlook. He also clears up common misconceptions about auditing, including the idea that it's just paperwork or checklist work, and reframes it as one of the fastest ways to build regulatory fluency, strengthen quality systems understanding, and expand career versatility across industries.The episode closes with practical steps for how engineers can get started: shadowing internal audits, learning audit frameworks and methodologies, taking formal training, and seeking mentorship from experienced auditors.Timestamps:00:00 – Why Engineers Should Consider Auditing01:10 – How Auditing Expands Technical Perspective05:26 – Misconceptions & Why Engineers Avoid Auditing11:25 – How to Start Your Audit Journey13:27 – Final Thoughts: Seeing the System, Not Just the SpecSubhi Saadeh is the Founder and Principal of Let's Combinate BioWorks and the host of Let's Combinate: Drugs + Devices. With a background spanning Quality, Manufacturing Operations, and R&D, he has supported the development and launch of hardware devices, disposable systems, and drug–device combination products across vaccines, generics, and biologics at some of the industry's largest medical device and pharma organizations.Subhi currently serves as the Working Group Chair for the Rx-360 Combination Products Working Group and previously served as the International Working Group Chair for the Combination Products Coalition (CPC). He has also contributed to ASTM Committee E55 and AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of MakingChips, we sit down with Charlie Hushek, President of Phoenix Heat Treating, whose family has been in the heat-Treating world for over a century. Charlie is a fifth-generation heat Treatinger—but his leadership story is anything but inherited. When he stepped into the business in 2020, he wasn't handed stability. He was handed a crisis. Within a matter of months, Phoenix Heat Treating lost its NADCAP certification—twice—suffered major operational setbacks, faced COVID turmoil, and endured the tragic loss of their general manager. For a company where more than 70% of revenue is tied to regulated aerospace work, this wasn't a stumble. It was a free fall. And it forced Charlie into leadership far earlier—and far harder—than he expected. But instead of shrinking from the challenge, Charlie transformed it into a total rebuild. He redesigned their QMS from the ground up, implemented true systems thinking, rewrote cultural standards, and introduced transparent, performance-driven practices that aligned every employee around shared values. The result? A thriving business, a revitalized culture, and a blueprint for how to rebuild a manufacturing company under extreme pressure. In this raw and energizing conversation, Charlie shares how Phoenix Heat Treatinging went from chaos to clarity, how culture becomes a competitive advantage, and what it takes to lead a team through uncertainty, fear, and burnout—and come out stronger on the other side. If you're leading a shop through change, growth, or crisis, this episode is a masterclass. Segments (1:29) Charlie's fifth-generation family history and the Phoenix Heat Treating story (2:19) The beginnings of Wesley Steel Treating and early industrial growth (3:43) Check out SMW Autoblok's massive catalog of products (5:15) Heat Treating as a long-standing, often overlooked "shadow industry" (5:45) Phoenix Heat Treating's early years, the move to Arizona, and generational transitions (7:34) Charlie's introduction to the business, working second shift, and learning operations (8:53) Phoenix Heat Treating's modern operations: five shifts, fast turn times, and business units (10:40) The importance of NADCAP certification and the challenges that come with losing it (12:45) Climbing out of crisis, stabilizing the business, and confronting hard truths (18:55) Internal emotions, team reactions, turnover, and the "burn the boats" mentality (22:06) Rebuilding from 50 employees to 80 through culture, transparency, and momentum (23:30) How primes issued waivers and partnered with Phoenix during the crisis (25:17) Working with customers to maintain flow on critical aerospace and defense parts (27:42) What's Your Method? 30-taper machines (34:43) The honesty and transparency you'll experience working with Phoenix Heat Treating (35:55) Building culture from the ground up and defining core values (39:01) Using employee surveys to define core values: teamwork, positivity, detail, work ethic (41:38) Embedding culture in hiring, onboarding, and daily expectations (45:30) Profit sharing, pay transparency, and rewarding performance (49:20) Applying the playbook to the newly purchased machine shop (52:53) Incentivizing change and gaining buy-in through aligned rewards (54:45) The importance of defining winning, alignment, and standards (58:23) Why we created Hire MFG Leaders (and why you should use it) (58:50) Charlie's "playbook," open-book management, and The Great Game of Business Resources mentioned on this episode The honesty and transparency you'll experience working with Phoenix Heat Treating Connect with Charlie Hushek on LinkedIn Where to check out SMW Autoblok's massive catalog of products Why we created Hire MFG Leaders (and why you should use it) The Great Game of Business Connect With MakingChips www.MakingChips.com On Facebook On LinkedIn On Instagram On Twitter On YouTube

In this episode of The Quality Hub: Chatting with ISO Experts, host Xavier Francis welcomes back Suzanne Strausser, VP of Consulting and Development at Core Business Solutions, to explore the benefits of outsourcing QMS administration. Together, they break down what it means to outsource your Quality Management System administration, and why more small and mid-sized businesses are choosing this path. Suzanne shares how outsourcing saves time and money, ensures continuous compliance, and gives companies access to seasoned ISO professionals without the cost of a full-time quality manager. They discuss how Core's experts handle everything from document control to internal audits, keeping systems audit-ready and efficient, while still letting organizations maintain full control. With insights on scalability, improved compliance, and peace of mind, this episode highlights how outsourcing can transform QMS management from a burden into a business advantage.   Helpful Resources: How is ISO 9001 Implemented?:  https://www.thecoresolution.com/how-is-iso-9001-implemented For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015 Contact us at 866.354.0300 or email us at info@thecoresolution.com A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting

The FDA Group's Nick Capman sits down with Maria Vassileva, PhD—Chief Science & Regulatory Officer at the Drug Information Association (DIA)—for a grounded, forward-looking discussion on how regulators are actually using AI today, where the technology is going, and what life science organizations should be preparing for now.Maria draws on two decades of leadership across nonprofit, government-funded clinical research, and biomedical science programs—spanning patient registries, clinical trials, multi-stakeholder consortia, DEI initiatives, and regulatory strategy. As the head of DIA's global science and regulatory portfolio, she works closely with regulators, industry sponsors, academia, and technology developers to advance responsible, evidence-driven innovation.In this conversation, Maria breaks down the reality behind AI in the regulatory ecosystem: what's currently in use, how agencies are evaluating and validating tools, why risk-based tiers matter, and how the field is moving toward lifecycle oversight rather than one-time checks. She also highlights the ethical and equity considerations that must be embedded from the start and shares insights from global regulatory trends and DIA's convening role.Key topics discussed include:How regulatory agencies are already using AI internally for document-heavy workflows, safety surveillance, and information retrievalWhy validation must focus on end-to-end workflow integrity, not just the modelThe emerging role of risk-based tiers for AI-enabled toolsThe importance of lifecycle control frameworks such as TPLC and PCCPsGlobal convergence themes around transparency, bias mitigation, and human accountabilityHow agencies are preparing for increasing AI adoption—and what industry teams should be doing nowDIA's role as a neutral convener helping harmonize expectations and accelerate responsible innovationAbout The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

MedBoard   EU Joint clinical assessment procedure -  EU 2025/2086 regulation for reimbursement in the EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502086 Team-NB position paper on Companion diagnostics - Significant changes rules: https://www.team-nb.org/wp-content/uploads/2025/10/Team-NB-PositionPaper-IVDR-Significant-changes-V2.pdf MDR and IVDR put at risk transplantation - Donor Screening and SoHo preparation: https://www.edqm.eu/documents/52006/162284/PA-PH-TO%20%2824%29%2018%20%E2%80%93%20Risks%20to%20safety%20and%20quality%20in%20donor%20screening%20and%20SoHO%20preparations%20due%20to%20poor%20implementation%20of%20the%20MDR%20and%20IVDR%20%E2%80%93%20CD-P-TO%20Position%20paper%20%E2%80%93%20October%202025.pdf/51d5efb2-4611-13ad-76a0-b5710b371248 Dedicated proportionate regulatory pathway for Niche fields Article 5(5.g) requirements to the highest risk categories (Health institutions to create documentation for the products) Update of MDCG guidance on In-house devices to better reflect the operational reality. Off-label use and RUO are not falling on Article 5.5 so grey zone.   Team-NB proposal for MDR & IVDR - 5 topics on the agenda:  https://www.team-nb.org/nbs-views-on-mdr-and-ivdr-review-process/ Early dialogue: Use of this to talk to Notified Bodies Article 61.10 & WET: Update for more clarity. Narrow the scope. Digitalisation: Machine readable documents, AI to support simulations to reduce Animal testing. Coding for MD and IVD Designation and recertification: For Notified Bodies Breakthrough: Coordinated pathway with challenge to generate Clinical Data. Notified Bodies Count - S New comers for MDR and IVDR:  SGS Fimko oy (IVDR 19): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1016921 ICIM S.P.A. (MDR 51) : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43747&filter=notificationStatusId:1 Notice (MDR): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1020121 Standards New Harmonized Standards - Clothing and sterilisers: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502078 Biocompatibility ISO TS 23485: https://www.linkedin.com/posts/melazzouzi_iso13485-iso-medicaldevice-activity-7393773266689228801-d7LM?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI UK Reliance with US FDA - Harmonization is ongoing: https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai Service eIFU with free access -Test it and let us know : https://Easyifu.com eQMS for a structured Quality Management System - Get your demo: https://eqms-smarteye.com/ Magazine eMagazine . EMD Mag Free- Are Notified Bodies still the right model: https://easymedicaldevice.com/emd-mag/ ROW US FDA: Pre-RFD -:Combination product: https://www.fda.gov/media/189466/download US FDA: QMSR guidelines -: How to create a QMS: https://www.fda.gov/media/189345/download   PODCAST Podcast review -  What happened in October 2025 Episode 357 - Highlights from La Rentrée du DM 2025: https://podcast.easymedicaldevice.com/357-2/ Episode 358 - Clinical Evidence under EU MDR - Why so many dossier fail (And how to fix it): https://podcast.easymedicaldevice.com/358-2/ Episode 359 - Real World Evidence - How to use it right for FDA and EU: https://podcast.easymedicaldevice.com/359-2/ Episode 360: US Government Shutdown - What FDA can still be doing? Rob Packard: https://podcast.easymedicaldevice.com/360-2/ Episode 361 - Automatisation of your QA RA Job with AI - Hatem Rabeh:  https://podcast.easymedicaldevice.com/361-2/

This episode dives into the complex and often misunderstood MedTech market in China, featuring Elaine Tan, creator of MedTech Chopsticks, who translates the nation's stringent regulatory language into actionable insights. Elaine and host Etienne Nichols discuss the substantial risks and rewards of bringing a medical device to China, highlighting the country's rapid execution, intense internal competition, and the shift from low-end manufacturing to a focus on high-level innovation. A key risk is that existing international certifications (like ISO and IEC) do not guarantee compliance, requiring local type testing and adherence to specific national standards.The conversation addresses how global medical device companies can structure their strategy amid ongoing geopolitical shifts and the "China for China" policy, which favors domestic products through initiatives like the Volume-Based Procurement (VBP). Strategies such as the dual-strategy approach—localizing low-consumable manufacturing while protecting high-technology IP through joint ventures or careful CMO/CDMO selection—are explored as pragmatic ways to secure market presence and margin. Understanding the regulatory landscape, particularly the NMPA's 2021 overhaul, is crucial for success.Finally, Elaine provides practical guidance for regulatory professionals intimidated by the market. This includes understanding the specific regulatory and clinical pathways, performing a gap analysis against Chinese standards (Product Technical Requirements or PTR), and the critical process of selecting and qualifying a local partner/agent. Elaine reveals a specific, often overlooked hurdle: the agent must possess an NMPA-approved CA (Certification Authorization) USB key to electronically submit registration files on behalf of the foreign manufacturer, a critical piece of the submission puzzle. The discussion also touches on leveraging special zones, like the Hainan Free Trade Zone, for crucial real-world data collection applicable to the Chinese population.Key Timestamps[02:40] Introduction to Elaine Tan, MedTech Chopsticks, and the show's focus on the China market.[05:05] High-level risks and rewards: complexity, lengthy registration, local testing requirements, and IP concerns.[08:08] Discussing the NMPA's 2021 regulatory overhaul and the geopolitical shift toward "China for China."[11:00] The Dual Strategy approach: balancing low-end localization with protecting high-tech IP.[14:48] Using CDMOs/CMOs for pilot projects to manage financial investment risk.[16:20] Leveraging the Hainan Free Trade Zone (Bo'ao region) for pre-market clinical data collection and urgent needs product access.[18:42] Ethological differences and their impact on clinical data justification (e.g., Pulse Oximeters).[20:17] NMPA predicate search: The importance of using the Chinese Classification Catalog to find registered, local predicate devices.[23:00] Guidance for overwhelmed regulatory professionals entering the China market: Clinical strategy and Product Technical Requirements (PTR).[25:52] Pitfalls in partner selection: The necessity of the NMPA-approved CA (Certification Authorization) USB key for submissions.[29:30] Partner qualification: Ensuring the agent can support Post-Market Surveillance (PMS) and QMS self-inspection requirements.[30:52] Final pitfall: International compliance (ISO/IEC) does not automatically ensure China...

This panel was recorded September 18, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠RQMplus.com⁠.Manufacturers often focus on MDR or IVDR and miss cross-cutting EU laws that impact CE marking, technical documentation, quality systems, and reporting. As a result, devices may be delayed, blocked from the market, or recalled, and manufacturers may suffer legal penalties and reputational harm.In this RQM+ Live! panel discussion, experts from BSI, Brabners, and RQM+ map how sectoral, horizontal, and national requirements fit together, how notified bodies assess them, and how to build an evidence-based path to EU market access.We cover practical implications of recent and emerging regulations, including:Batteries Regulation (EU) 2023/1542AI Act (EU) 2024/1689Packaging and Packaging Waste Regulation (EU) 2025/40European Health Data Space Regulation (EU) 2025/327You'll learn:About the market surveillance regulation (EU) 2019/1020 and EU Blue Guide.How to identify all applicable legislation for your product and verify coverage.What notified bodies expect to see and the typical level of scrutiny.How to structure your compliance register, QMS updates, and regulatory reporting.Transition timelines and planning tactics to avoid last-minute surprises.Who should listen: Regulatory, quality, clinical, legal, and product leaders responsible for EU market access for medical devices and IVDs.Panelists and moderator:Greg Griffin, PhD, MRSE – Technical Specialist, BSIClaire Burrows – Regulatory Partner, BrabnersChris Parr, PMP – Principal, RQM+Jaishankar Kutty, PhD – Vice President of Regulatory Affairs, Reimbursement, & Market Access, RQM+ (Moderator)--

This "Meet the Guru" episode introduces Alex Naber, a seasoned medical device consultant at Greenlight Guru, offering listeners a deep dive into his background and expertise. Alex shares his journey, beginning in bioengineering and progressing through roles in complaints, field action, design quality, and post-market quality management at a major orthopedic company (Zimmer Biomet). His experience highlights the crucial need for expert guidance in navigating complex MedTech regulations and quality management system (QMS) pathways.Alex and host Etienne Nichols discuss the immense value of having a diverse internal team of consultants to draw from—a collective knowledge base that helps solve complex problems for clients. They emphasize that quality professionals don't need to know "everything" but rather must have the right resources and a "beginner's mindset" to guide companies effectively. The conversation also explores how modern software, like Greenlight Guru's QMS and EDC solutions, eliminates common industry pain points, such as fragmented, error-prone spreadsheet-based design controls by building true, linked traceability directly into the eQMS.Finally, the discussion touches on the philosophical "why" of the medical device industry: the patient. Alex shares a personal story about how orthopedics improved his grandfather's quality of life, underscoring the importance of maintaining a patient-first ethos. They conclude by discussing the upcoming QMSR transition, reassuring listeners that compliance is manageable, especially for those already adhering to ISO 13485.Key Timestamps[01:50] Alex Naber's MedTech Career Path: From Bioengineering to Design Quality and Post-Market Management.[04:30] The Power of Pooled Expertise: Why Greenlight Guru's Consultant Team is a "Sherpa up the mountain."[07:35] The Problem with Spreadsheets: Comparing traditional Design Control methods to modern eQMS traceability.[11:00] Accelerating Compliance: How Greenlight Guru's QMS Templates dramatically cut implementation time.[13:30] The Bloated QMS: Why adopting procedures from large corporations may hinder small-to-midsize companies.[16:00] Design Quality Explained: Marrying R&D/Product Development with QMS compliance.[21:30] The MedTech Ethos: Focusing on the patient and improving quality of life.[27:00] CAPA Management Insights: The critical distinction between Correction and Corrective Action.[30:25] Navigating the QMSR Transition: Reassurance that compliance isn't "that deep" if you are already ISO 13485 compliant.Quotes"It's a rewarding thing to just understand that you don't need to know everything. I think that's a thing that... people should realize and they should reach out to other people that are smarter or more experienced in realms that they don't understand." - Alex Naber"I think what got me into MedTech was more of the ethos behind it... We're creating products to make patients' lives better, to impact our world, our society in a positive manner, to give a better quality of life to individuals." - Alex NaberTakeawaysSeek a Unified Quality Solution: Fragmented quality processes (e.g., design controls in spreadsheets separate from the QMS) introduce significant regulatory risk. Adopting an eQMS, like the Greenlight Guru QMS solution, creates true traceability and dramatically streamlines compliance.Design Quality as a Partner, Not Police: Design Quality Engineers should actively partner with R&D, not...

At the heart of The Prophets' vision are “The 24 Essential Supply Chain Processes.” What are they? Find out, and see the future yourself. Click here This episode, recorded live at the QAD Midwest Users Conference, brings together voices shaping the future of automotive supply chains. Hosts Jan Griffiths, Terry Onica, and Jim Liegghio sat down with leaders across the supply chain to explore the future of manufacturing, technology, and collaboration.French Williams from Royal Technologies began by sharing how his company approaches automation. Rooted in a culture of “better tomorrow than today,” Royal has built a model where IT and supply chain work hand in hand, co-developing solutions that allow the company to scale and respond to customer needs.Autokiniton's Andy Amstuz takes the mic next. As VP of IT and president of the Midwest User Group, he explains why user groups matter. The community becomes a lifeline when challenges hit.Autokiniton already puts real-time performance data in front of operators at every work center, proof that frontline visibility drives better decisions.Fresh off his keynote, QAD's new CEO, Sanjay Brahmawar, outlined his vision for ERP as a “system of action” rather than a “system of record.” He introduced QAD's Champion AI, designed to reduce mundane work, tackle complex challenges like inventory costs, and accelerate implementations through “Champion Pace.”For Sanjay, culture is as critical as technology. He points to Redzone's track record — 26% productivity gains, 81% more engagement, and 35% lower attrition — as proof that empowering shop-floor teams changes the game.Andrea Hyska and Jon Smith of Lacks Enterprises brought the conversation down to the plant level, sharing how their IT teams succeed by staying connected to the business. From extending QMS capabilities to implementing shop floor applications, they credit a collaborative culture and hands-on leadership with making automation practical and effective.AIAG's Fred Coe closes with where data exchange is heading. EDI is not going away, but APIs and Catena-X will complement it, which makes standardization and supplier voices at the table urgent. He reminds listeners that shaping the future requires participation, not waiting for others to decide the direction.By the end of the conference, a clear theme had emerged: culture drives adoption, community accelerates learning, and technology is only effective when people are fully engaged. At this conference, the future of automotive supply chains didn't feel theoretical; it felt like it was already being built, one conversation at a time.Themes discussed in this episode:The role of company culture in driving collaboration between IT, supply chain, and operationsHow automation helps tier two suppliers like Royal Technologies scale effectively and serve customers betterThe value of peer networks and user groups in supporting manufacturers through industry volatilityWhy empowering frontline workers with real-time production data strengthens decision-making on the shop floorThe shift from ERP as a “system of record” to ERP as a “system of action” under QAD's Champion AI visionWhy Lacks Enterprises prioritizes teamwork and floor-level engagement to ensure technology projects succeedThe growing importance of APIs and Catena-X in shaping the future of EDI and supply chain data exchangeThe risk suppliers face if they fail to engage in setting industry standards for connectivity and collaborationFeatured guests:Name: French...

In Part 2 of our conversation with certified lead auditor Jess Teasdake, we dig deeper into what it really takes to build an efficient, audit-ready quality management system (QMS). If you caught Part 1, you heard us talk through the big picture: certifications, audits, and what separates a good QMS from a bad one. This time, we're getting tactical. We're not just talking about passing an audit—we're talking about building a system that supports your team, reduces risk, and eliminates waste across your business. From risk registers and RPN scoring to digitizing your paperwork and planning with cross-functional teams, we cover the actual tools and habits that make quality real on the shop floor. Along the way, we share stories from our own shops—what's worked, what hasn't, and how integrated technology has changed the game. We've lived the paper-chasing, binder-filled chaos that too many shops call a QMS. And we've seen what happens when you replace it with a connected system that actually reflects how your shop runs day to day. If you're working toward certification—or just want to build a culture of quality that doesn't require heroics to maintain—this episode is your blueprint. Segments (0:26) Grow your top and bottom line with CLA (2:53) Recap of Part 1 + why efficient QMS design matters in regulated industries (3:33) Defining and mapping core processes from RFQ to shipment (6:23) Risk-based thinking: risk registers, RPN scoring, and real-world examples (9:11) Tracking and improving risk scores over time with team input (11:33) Cross-functional planning: involving machinists, programmers, and QA early (12:57) Ballooned drawings, IPCs, and quality planning before the job hits the floor (14:01) Integrated quality checkpoints: from receiving to signoffs and inspection (16:20) Why going paperless saves time and improves accuracy (17:56) Join us at Top Shops 2025! (18:51) Quality as a company-wide responsibility—not a department (21:12) Digital documentation strategy and collaboration tips (23:26) How to implement QMS step by step (26:55) Linking vs. integrating: what real QMS tech should do (29:50) Before & after ProShop: how integrated QMS changed our audit process (33:46) Certification myths: ISO, AS9100, and audit readiness every day (35:53) Why QMS should be built into your tech stack and team culture (38:07) Use Hire MFG Leaders to recruit the next level of talent Resources mentioned on this episode Machine Shop MBA: Planning for Precision Register for Top Shops 2025 now: Get 20% off with code: MAK20 Connect With MakingChips www.MakingChips.com On Facebook On LinkedIn On Instagram On Twitter On YouTube