RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. In each episode, join Regulatory Compliance Associates® (RCA) and industry thought leaders as we navigate the issues that matter to you most.
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Listen Medical Device Regulation and Standards
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Welcome to Food Tech Talk: Supply Chain Insights From Farm to Fork, a bite-sized podcast discussing the latest trends and technology in the food and supplements industries, featuring conversations with regulatory experts, quality and safety champions, and thought leaders across the industry. Together, we are on a mission to change the food and dietary supplement industry for the better. In short snippets, guests will discuss a range of topics, from regulatory compliance to sustainable operat ...
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A Ropes & Gray (RopesTalk) podcast series, focused on current trends in FDA regulatory law, as well as other important developments affecting the life sciences industry.
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With hemp being legalized only recently, legal and regulatory regimes concerning the crop and its products such as CBD are continually evolving. Jonathan Miller, who helped craft much of federal and state hemp laws in his role as General Counsel of the US Hemp Roundtable, hosts a biweekly podcast in which he engages in 15-20 minute discussions of cutting-edge legal issues facing the industry. Jonathan speaks on each program with subject matter experts from Frost Brown Todd’s nationally leadi ...
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Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to li ...
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Global Medical Device Podcast powered by Greenlight Guru
Greenlight Guru + Medical Device Entrepreneurs
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
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RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing. RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ t ...
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This Food Industry focused podcast brings together Xtalks editorial staff to share insights into the latest B2B industry news. Xtalks connects professionals in the life science, medical device, and food industries with useful content like webinars, job opening, articles and virtual meetings.
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The $1 Pound Show dives deep into the cannabis industry. We discuss and document the transition happening with marijuana. From the black market to grey market finally to a regulated market. California has recently legalized cannabis and is currently figuring out it's regulations. Guests include, cultivators, extractors, lawyers, doctors other business owners.
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Our goal in this podcast is to support natural product brands, dietary supplement companies, functional food and beverage companies, and nutraceutical industry professionals by offering interviews with top industry experts. These interviews will contain best practices, trends, recent news, and other insights as they relate to business ops, supply chain, quality, science and regulatory, manufacturing, marketing, strategy, branding and more.
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I work with honest, open-minded, and forward-thinking people. I created The Experiential Knowledge Solutions™. It helps you increase the performance by decoding the tacit knowledge of your team.
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Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach t ...
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160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!
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In this episode of *Let's Combinate*, Subhi delves into the critical distinctions between drug tech transfer and device design transfer, especially pertinent to combination products. Sue comprehensively outlines the regulatory frameworks governing each process—ICH Q10 for drug transfer and ISO 13485 for device design transfer. The episode discusses…
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The Future of Digital Food Safety Management with Eric Moore
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In this episode of Food Tech Talk, Lydia Adams speaks with Eric Moore about the evolution of digital food safety management systems. Eric shares his unexpected journey into food safety, beginning in the early 2000s when he transitioned from hospitality management to becoming a designated food safety professional at the Pennsylvania Convention Cente…
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Holly Cotter, Senior Consultant | Excellence Spotlight
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧗♀️ Our newest 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview is an especially fun one! From National Geographic subscriptions to successfull…
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Aaron Nosbisch and the Rise of Hemp Beverages
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Jonathan Miller interviews Aaron Nosbisch, the CEO of Brez, about the exciting new category of hemp beverages, the challenges and the opportunities. If you have questions about the episode or ideas for Hemp related topics, email us at hemplegallyspeaking@fbtlaw.com. Hemp Industry questions covered in the episode: What are the factors behind the rec…
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#388: Elements of an Effective CAPA Program
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In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems. Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions…
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In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesn’t provide much information. So, let’s review that together. Who is Adam Isaacs Rar? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsm…
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New FDA draft guidance for Chemical Analysis
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In this episode of RCA Radio, host Brandon Miller is joined by Nelson Labs Director of E&L Raymond Colton as well as board certified toxicologist Dr. Sarah Campbell also from Nelson Labs to discuss the recent draft FDA GUIDANCE DOCUMENT: Chemical Analysis for Biocompatibility Assessment of Medical Devices. Listen in as we cover why this guidance wh…
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159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin
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In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across various organizational structures. Through their engaging discussion, they highlight the independence of quality units to prevent conflicts of interest, drawing parallels with finance and HR functions. The…
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The Demise of Chevron and Implications for Future APA Challenges
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On this episode of Ropes & Gray’s podcast series, Non-binding Guidance, life sciences regulatory and compliance partner Greg Levine and counsel Beth Weinman are joined by appellate and Supreme Court practice head Doug Hallward-Driemeier to explore the Supreme Court's recent landmark decision in Loper Bright, which ended the long-standing practice o…
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What makes a successful regulatory submission from a clinical trial perspective? (Part 3/3) – MedTech CRO: Regulatory Expertise Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In the final installment of this three…
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Live! #83 – Structured Dialogue: How to Engage with Notified Bodies
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This presentation and panel was recorded 4 October 2024. We encourage you to download the slides presented during this session by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in a…
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#387: The case for Real World Evidence Studies
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In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation. Simon breaks down NEST's critical role in catalyzing the use of RWE to stre…
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in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team. Who is Georg Digel? I’ve reviewed too many Medical Device CAPAs over the last 10 years. I think I’ve seen almos…
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158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show
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In this episode, host Subhi reflects on three years of podcasting, drawing analogies to strength training and discussing the incremental progress achieved. The episode highlights the importance of consistency in podcast production, inspired by Robert Greene's 'Mastery,' and outlines plans for the show's future evolution.00:00 Welcome and Podcast Jo…
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Building Trust Through Technology: Chris Latta's Vision for Food Safety
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Join Lydia Adams as she speaks with Chris Latta, Director of Business Development at Kwik Lok, about the evolving landscape of food traceability and transparency. With over 15 years of experience in global sales, marketing, sustainability, and industrial design, Chris brings a unique perspective to the conversation. Chris discusses Kwik Lok's 70-ye…
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What makes a successful regulatory submission from a clinical trial perspective? (Part 2/3) – MedTech CRO: Regulatory Expertise Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In part two of a three-part series, Jais…
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Christine Anderson, Principal Consultant | Excellence Spotlight
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. ⭐ After highlighting many members of our Jordi Labs, an RQM+ Company team in the past two months, we're returning to RA/QA thi…
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Boone Cutler and the Fight for Access by Veterans for Hemp Products
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Jonathan Miller interviews Boone Cutler, the chairman of Spartan Sword, a veterans’ advocacy organization, about continuing battles our nation’s veterans face in ensuring access to hemp and CBD products for health and wellness purposes. If you have questions about the episode or ideas for Hemp related topics, email us at hemplegallyspeaking@fbtlaw.…
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What makes a successful regulatory submission from a clinical trial perspective? (Part 1/3) – MedTech CRO: Regulatory Expertise Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In part one of a three part series, Jaisha…
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#386: The Danger of In-Home Use Medical Devices, Pt. 2
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In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices. The discussion centers on critical topics such as labeling, usability challenges, and the future of medical devices in home settings. They explore how these …
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Medboard: https://www.medboard.com/ EUROPE TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf MDCG…
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157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura
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In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked topic of design inputs in product development. Chuck highlights how poor design inputs can slow down product development and lead to issues in market compliance. He stresses the importance of spendin…
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Michael Louis, Chemist II (Jordi Labs) | Excellence Spotlight
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 Our run of 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interviews with our Jordi Labs, an RQM+ Company team members continues with Christine Santag…
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#385: The Trouble with Home-Use Devices, Pt. 1
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In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings. They explore how home use devices, su…
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In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So check this. Who is Lucas Pianegonda? Lucas Pianegonda is an expert for medical grade plastics, material testing and materi…
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Best Practices In AE Reporting In Clinical Trials – MedTech CRO: Clinical Trial Execution Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* 🚨 Watch our newest video to learn best pract…
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156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar
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On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc. On this episode, Laxman, highlights the differences in regulatory oversight and risk management between medical devices and pharmaceuticals, the trend towards home administration of drugs, sustainability goals, and the chall…
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Food Safety Culture and Sustainability: Insights from Steven Foster
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Join Lydia Adams on Food Tech Talk as she interviews Steven Foster, a seasoned expert in food safety and quality assurance with over 30 years of experience in the food industry. Currently serving as the VP of Food Safety and Quality at Wholesale Produce Supply, Steven shares his journey and the defining moments that shaped his approach to food safe…
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Effective and Efficient Safety Management In Clinical Trials – MedTech CRO: Clinical Trial Execution Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In our latest clinical trials video, Manager o…
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Live! #82 – MDR and IVDR Amendments: Strategies for Supply Interruption Compliance
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This presentation and panel was recorded 12 September 2024. We encourage you to download the slides presented during this session by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in …
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#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends
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In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality …
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Anthony Grice, Chemist III (Jordi Labs) | Excellence Spotlight
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues as Christine Santagate, RAC chats with Dr. Anthony Grice, a leading chem…
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155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach
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On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie…
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In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US. Who is Claire Dyson? Who is Claire Dyson? Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery …
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#383: What Standards Apply to My Device?
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In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development. Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuri…
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Largest Food Companies by Market Cap + Supermarket Baby Food Study
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The landscape of publicly traded food companies is constantly evolving, with consumer preferences, technological advancement and global challenges all playing a role in shaping the industry. In 2024, these factors have culminated in a diverse and competitive market where the largest publicly traded food companies dominate. In this episode of the Xt…
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154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell
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On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma en…
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Chemistry to Quality: From Dr. Stephen Sims' Journey in Food Safety
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In this episode of Food Tech Talk, Lydia Adams sits down with Dr. Stephen Sims, a distinguished food safety and quality assurance expert. With a background in chemistry and extensive experience in the food industry, Dr. Sims offers unique insights into the world of food safety auditing and quality management. Dr. Sims takes us through his journey f…
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In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make to do it right. Who is Cesare Magri? Cesare Magri is the founder and CEO of 4BetterDevices GmbH. He and his team of medical doctors and biostatisticians assist medical device and in-vitro diag…
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Craig Young, Lab Coordinator (Jordi Labs) | Excellence Spotlight
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues this week, as Christine Santagate, RAC is joined by Lab Coordinator Crai…
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Michael Morales, Chemist II (Jordi Labs) | Excellence Spotlight
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues this week, as Christine Santagate, RAC is joined by Chemist II Michael M…
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#382: Design of Experiments - How and When to Use DOE
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In this episode, Etienne Nichols interviews Perry Parendo, an expert in Design of Experiments (DOE), about the practical application of DOE in medical device development. They discuss how DOE can be used to better understand systems, reduce risk, and solve complex problems, especially in R&D and manufacturing processes. Perry shares insights from h…
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153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system…
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