Certification & compliance
Manufacturing & supply chain
724 episodes across 41 shows cover certification & compliance. The shows that cover it most are Global Medical Device Podcast, Let's Combinate and People of Packaging. The most recent, from 13 Oct 2026, is “#475: Rethinking FDA Guidance: Why Non-Binding Documents Define Your Regulatory Strategy” from Global Medical Device Podcast.
Getting a product legally to market: FCC, CE, UL, EMC testing, FDA, safety standards, labelling and regulatory strategy.
724 episodes from 41 shows, most relevant and most recent first.
724 episodes
#475: Rethinking FDA Guidance: Why Non-Binding Documents Define Your Regulatory Strategy
Mike Drues, president of Vascular Sciences, explains that FDA guidance documents represent the agency's 'current thinking' rather than binding law, urging manufacturers to treat them as tactical starting points rather than immutable rules…
257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products
Subhi Saadeh, a consultant and auditor specializing in combination products, explains the CGMP requirements under 21 CFR Part 4 for products containing both drug and device elements. She details the scope of single-entity and co-packaged…
Where it comes up0:00
R&D RADIO: Non-GMO, Organic, or Gluten-Free? How to Decide Which Certifications Are Worth It
Esther Levy, founder of Evolve Food Consultants, explains the complex trade-offs founders face when deciding on third-party certifications like USDA Organic, Non-GMO, and Gluten-Free. She highlights that while organic is theoretically…
#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls
Nikhil Mangale, Vice President of Quality at Kapstone Medical, discusses the real-world impact of the FDA's Quality Management System Regulation (QMSR) based on seven months of inspection data. He identifies the top five FDA citations as…
#255 - Mini episode: Non-UPF Verified Update
Hans Eisenbeis, Director of Mission and Messaging at Non-UPF Verified, provides an update on the organization's certification program for ultra-processed foods (UPFs) following its major rollout at Expo West. He explains that Non-UPF…
The Return to the Chamber of Mysteries
Bryan Cantrill and Adam Leventhal of Oxide Computer Company are joined by Robert "RFK" Keith, Dan Chirpich, and Stu Donnan to discuss the company's recent struggle with FCC EMC compliance for their next-generation rack. The team details…
#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment
Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), explains the regulatory complexities of combination products, focusing on how the Primary Mode of Action (PMOA) dictates FDA oversight. He details the…
256 - The New FDA Inspection Playbook: Where to Start with QMSR
Subhi Saadeh, founder of Let’s Combinate, introduces a four-part series on FDA inspection readiness under the new Quality Management System Regulation (QMSR), explaining how the retired QSIT framework has been replaced by Compliance…
253 - FDA Is Making Big Changes to Its Inspection Approach
Eric Pittman, former Bioresearch Monitoring West Division Director at the FDA and now VP at Project Farma, explains the FDA's transition from a specialized program-aligned inspection model back to a broader, medical-product-specific…
348 - Cracking the Code of Label Compliance with Lauren Rockteacher
Lauren Rockteacher, founder of Proof and Panel, explains the critical importance of regulatory compliance in food and dietary supplement labeling, distinguishing between the two categories based on structure-function claims. She warns…
#024: Shipping Firmware Under the CRA: Nicolas Schieli on the Questions Everyone’s Asking, and the Ones They Should Be Link:
Nicolas Schieli, VP of Product Security at Nordic Semiconductor, joins François Baldassari and Chris Coleman to explain the EU Cyber Resilience Act (CRA) for connected products. They detail the immediate 24-hour vulnerability reporting…
250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?
Subhi Saadeh, founder of Let's Combinate, analyzes the 2026 update to PIC/S PI 006-4, the first major revision to qualification and validation recommendations in nearly 20 years. He details how the document shifts from the 2007 PI 006-3…
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#449: 7 Pitfalls of International MedTech Expansion
Mike Drues, President of Vascular Sciences, joins host Etienne Nichols to discuss the regulatory pitfalls international medical device companies face when expanding into the U.S. market. Drues challenges the assumption that a CE Mark…
#445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech
Thor Rollins, a leader at Nelson Labs and convener of the ISO committee revising ISO 10933-1, explains the 2025 standard's shift from checkbox testing to a risk-based approach aligned with ISO 14971. He details new requirements for…
#216 - Food Labeling Law 101 with Lauren Handel
Lauren Handel, founder of Handel Food Law, explains the regulatory framework and litigation risks for CPG brands, distinguishing between FDA-regulated foods and USDA-regulated products. She details specific claim categories including…
Why 90% of Electronics Fail EMC Tests and How to Fix It
Karen Burnham, chief engineer and founder of EMC United, explains why 60-90% of electronics fail EMC tests on the first attempt, citing counterintuitive antenna effects and misleading data sheet advice like ground plane splits. She details…
#438: QMSR Mythbusters Episode
Host Etia Nichols from Greenlight Guru explains the FDA's new Quality Management System Regulation (QMSR), which replaces 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, with a mandatory enforcement date of February 2, 2026…
Where it comes up0:31
242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start
Subhi Saadeh, founder of Let’s Combinate, outlines six audit strategies from the ASQ Certified Quality Auditor (CQA) Body of Knowledge for pharma, biotech, and combination product audits. He details the Tracing, Process Approach…
Where it comes up0:00
237 - ICH Q10: The Pharmaceutical Quality System
Subhi Saadeh, founder of Let’s Combinate, explains the ICH Q10 guideline on the Pharmaceutical Quality System (PQS), distinguishing it from certifiable standards like ISO 9001 and ISO 13485. He details how PQS augments regional GMPs across…
Where it comes up0:00
Ep. 42 - Certifications
Steven Hoss and Lucy Trey Park of Opulo discuss the complex and expensive process of obtaining FCC and CE certifications for the Lumen PMP V4 3D printer. They detail the four main categories of EMC testing—radiated/conducted emissions and…
329 - Future-Proofing Fresh Food Packaging: UK Lessons on EPR, Food Waste, and Data with Tom Stone (Bakkavor)
Tom Stone, Senior Packaging Development Controller at Bakkavor, explains how the UK’s Plastic Tax and Extended Producer Responsibility (EPR) legislation are forcing a data-driven approach to fresh food packaging. He details Bakkavor’s…
234 - ICH Q7: The GMP Framework for API Manufacturing
Subhi Saadeh, Founder of Let’s ComBinate, provides a detailed walkthrough of ICH Q7, the GMP framework for Active Pharmaceutical Ingredient (API) manufacturing. He explains that unlike other guidelines, Q7 covers the full lifecycle from…
#460: FDA AI Regulations: Master the QA/RA Skills to Stay Ahead
Etsy Nichols discusses the evolving FDA regulatory landscape for AI-enabled medical devices, highlighting the establishment of the Digital Health Center of Excellence and the shift toward rigorous documentation over algorithmic…
#436: Do ISO 13485's Production Controls apply to SaMD?
Adnan Ashfaq, founder of Simply Medica, explains how to apply ISO 13485 production controls to Software as a Medical Device (SaMD), arguing that hardware-centric clauses must be interpreted in a 'virtual manufacturing space.' He details…
U.S. Navy's Captain Deichler on AM in the Submarine Industrial Base
Captain Jason Deichler, Chief of Staff for Submarine Programs at the U.S. Navy, explains the Navy's strategy to achieve a 'one plus two' production goal (one Columbia-class and two Virginia-class submarines annually) by rebuilding a…
How Design-First Thinking Supercharges Manufacturing Performance with Clarity Design Founder Tom Lupfer
Tom Lupfer, President and Founder of Clarity Design, explains how integrating engineering and manufacturing under one roof creates a competitive advantage for his Southern California-based EMS company. He details how data from Ko Young…
Where it comes up4:19
#432: China MedTech Compliance: Regulatory Risks, Rewards, & Strategy with Elaine Tan
Elaine Tan, creator of MedTech Chopsticks, explains the regulatory and strategic complexities of entering the Chinese medical device market, highlighting the NMPA's 2021 overhaul and the 'China for China' policy. She details the necessity…
228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently
Subhi Saadeh, Founder of Let's Combinate, explains ICH Q5, the regulatory guideline for biological and biotechnological products derived from living systems. He details how Q5 addresses viral safety (Q5A), cell substrate controls (Q5D)…
Where it comes up0:00
226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification
Elaine (Yi Ling Tan) of MedTech Chopsticks explains that Western manufacturers often fail in China because they assume EU or US approvals (IEC/ISO, FDA) translate directly, whereas China requires compliance with local GB (national) and YY…
#157 - Buyer Spotlight: Jason Murrell, JIMBO’S
Jason Murrell, Director of Grocery at JIMBO’S, a San Diego-based organic retailer, explains how the company prioritizes regenerative organic certification (ROC) and strict ingredient standards to curate its ~13,000 SKUs. He details the…
What is Device Lifecycle Management? | Northern.tech's Eystein Stenberg | Internet of Things Podcast
Eystein Stenberg, CTO and co-founder of Northern.tech, explains that device lifecycle management (DLM) is essential for OEMs transitioning to software-driven business models. He details the five stages of DLM—design, manufacture…
226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions
Subhi Saadeh, Founder of Let's Combinate, explains the ICH Q4 framework, which shifts the responsibility for pharmacopeial equivalence from sponsors to regulators via the Pharmacopoeial Discussion Group (PDG). He details how ICH Q4A…
Where it comes up0:00
#429: MedTech Regulatory Risk: Navigating the FDA During a Government Shutdown
Michael Nilo, President of Nilo Medical Consulting Group and former FDA Scientific Reviewer, explains how a U.S. government shutdown impacts the Food and Drug Administration (FDA) and medical device companies. He details that while new…
#451: Building a MedTech Powerhouse: The 5 Stages of Founder Success
Etienne Nichols, host of the Global Medical Device Podcast, outlines the five stages of building a medical device company, emphasizing that success depends on hiring the right specialized experts at each phase rather than just having good…
Supply Chain Challenges in Medical Device Manufacturing
Supply chain executive Simon Hinds discusses the unique complexities of medical device and life sciences supply chains, contrasting them with automotive and consumer electronics. He explains how regulatory barriers, traceability…
Intro EMC: Compliance, Opportunities & Pitfalls with Anton Tishchenko
Anton Tishchenko, founder of PCBforEMC.com and Dr. EMC YouTube channel, discusses EMC compliance strategies, common PCB design mistakes, and his PhD research on 6G metasurfaces. He highlights that EMC testing has a 50% first-time failure…
#416: Unpacking Common FDA Compliance Gaps: Pre-Market vs. Post-Market Realities
Mike Drues, a regulatory consultant and former FDA subject matter expert, joins host Etienne Nichols to critique the FDA's recent identification of 'lack of documentation for software changes,' 'design creep,' and 'marketing beyond…
225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes
Subhi Saadeh, Founder of Let's Combinate, explains the ICH Q3 family of guidelines, which establish a risk-based framework for controlling impurities in drug substances and products. He details how Q3A covers drug substance synthesis, Q3B…
Where it comes up0:00
224 - ICH Q2 Explained: What Analytical Validation Really Requires
Subhi Saadeh, Founder of Let's Combinate, explains the ICH Q2 guideline for analytical procedure validation, emphasizing its role in harmonizing global regulatory expectations for drug substance, drug product, and the drug element of…
Where it comes up0:00
IoT Connectivity: Trends and Strategies | Transforma Insights' Matt Hatton | Internet of Things Podcast
Matt Hatton, Founding Partner at Transforma Insights, discusses the 2024 CSP IoT Peer Benchmarking report, highlighting the industry shift from pure connectivity providers to device-to-cloud solutions and the rise of consulting services…
Ep. 10: The Scale-Readiness Gap in Robotics | The Robo Success Podcast
Chioma Aso, Founder and Principal Consultant at Polymavericks Engineering, explains the 'scale-readiness gap' in robotics, arguing that a working prototype is a false indicator of manufacturing repeatability. She details her five-pillar…
223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations
Subhi Saadeh, host of Let's Combinate and founder of Let's Combinate BioWorks, breaks down the 2025 draft update to the ICH Q1 stability guideline, explaining that the new 100+ page document consolidates legacy guidelines rather than…
Where it comes up0:00
#414: Why Global Certification is the Future of Clinical Research in Latin America
Julio Martinez-Clark, CEO of BioAccess, explains the launch of GCSA site certification and IAOCR individual accreditation in Latin America, designed to standardize clinical trial quality and de-risk sponsor investments. He highlights…
#458: What the FDA Actually Says About AI in Medical Devices
Etienne Nichols explains how the FDA's adoption of its internal AI tool, Elsa, signals that AI in medical devices is a regulated reality requiring strict adherence to new standards. He argues that companies should view AI like electricity…
Fatigue & Fracture Behavior in AM Materials with Nima Shamsaei of Auburn University
Nima Shamsaei, a professor at Auburn University and Director of the National Center for Additive Manufacturing Excellence (NCAME), discusses the fatigue and fracture behavior of additive manufacturing (AM) materials. He explains that…
PCB Connectors That Survive Space, Shock & 500 Thermal Cycles
Shane Dabrowski, a Field Applications Engineer at Samtec, explains how the company’s Severe Environment Testing (SET) and MIL-DTL-55302 lot-based testing validate standard connectors for military, aerospace, and LEO satellite applications…
#406: Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 2
Etienne Nichols and regulatory affairs expert Mike Drues discuss the regulatory pathway for switching a medical device from prescription (Rx) to over-the-counter (OTC) status. They explain that removing the healthcare provider from the…
222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series
Subhi Saadeh, founder of Let's Combinate BioWorks and host of the Let's Combinate podcast, provides a high-level orientation to the International Council for Harmonisation (ICH) guidelines, explaining their organization into Quality (Q)…
221 - What Is ICH and Why It Matters
Subhi Saadeh, host of Let's Combinate and founder of Let's Combinate BioWorks, explains the International Council for Harmonisation (ICH) and its critical role in drug-device combination products. He details the history of ICH, from its…
Where it comes up0:00
When Production Overtakes Prototyping: Materialise’s Next Phase of AM
Bart van der Schuren, CTO of Materialise, explains how the company transitioned from a 1995 service bureau to a production powerhouse, recently surpassing prototyping with serial manufacturing. He details the three pillars of…