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Episode 61: AI Enabled Medical Devices Part 2
22 July 2025
Episode #61 of "Medical Compliance With Clarissa". In Part 2 of a 2-part series on AI Enabled Medical Devices, host Clarissa Benfield is joined by Wayne Stewart, Intertek VP of Global IoT and AI, and Nico Schmidt, Intertek AI Architect. In this episode Clarissa, Wayne and Nico explore deeper topics including adaptive AI, retraining models, cybersecurity risks, and post-market performance monitoring. They discuss global regulations like the EU AI Act and FDA guidance, and explain what manufacturers need to know about transparency, explain ability, and testing frameworks. This episode is packed with practical insights for medical device developers aiming to integrate AI safely and effectively, while staying ahead of evolving standards. Whether you’re deep into development or just exploring AI applications, this episode offers critical takeaways.
Episode 60: AI Enabled Medical Devices Part 1
08 July 2025
Episode #60 of "Medical Compliance With Clarissa". In Part 1 of a 2-part series on AI Enabled Medical Devices, host Clarissa Benfield is joined by Wayne Stewart, Intertek VP of Global IoT and AI, and Nico Schmidt, Intertek AI Architect. Together, they explore how AI is transforming diagnostics, risk management, and patient care, all while navigating data privacy, model validation, and regulatory compliance. Learn about common AI models, challenges around data diversity, and how manufacturers can ensure performance and safety in real-world use. Whether you're a medical device developer or just curious about the future of healthcare innovation, this episode offers valuable insight into where AI in medicine is heading next. Tune in and join the conversation.
Episode 59: "Medical Lasers" with Jessica Smith
17 June 2025
Episode #59 of "Medical Compliance With Clarissa". In this episode, Clarissa Benfield is joined by Intertek Senior project engineer and laser safety expert, Jessica Smith, to demystify the complexities of medical laser regulations. With over 18 years of experience, Jessica walks us through FDA laser classifications, the differences between IEC 60825 and 60601-2-22, and the critical role of risk management in designing laser-based devices. They discuss how essential performance is defined for lasers, tips for early-stage compliance, and why understanding international deviations is key for global market access. Whether you're designing surgical lasers, cosmetic treatment devices, or diagnostic equipment, this episode provides invaluable insights into safe, effective, and patient-centered design.
Episode 58: "Patient Monitors" with Min Ying
03 June 2025
Episode #58 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield sits down with Intertek Engineer and Medical Team Lead, Min Ying, to explore the world of patient monitors—how they’ve evolved, how they’re tested, and what manufacturers need to know to meet global compliance standards. From wall-mounted bedside units to app-based wearable tech, the conversation dives into the IEC 60601 family of standards, the growing importance of risk management, and what the future might look like with new regulations emerging. Min shares real-world advice on designing with standards in mind, avoiding costly delays, and collaborating effectively with testing labs. A must-listen for anyone developing next-gen monitoring technology.
Episode 57: "Med Device Chemical Characterization" with Tino Otte
20 May 2025
Episode #57 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield is joined by Tino Otte, Director of Business Development at Intertek Basel, to break down the FDA’s recent draft guidance on chemical characterization for medical devices. Tino offers expert insight into the significant changes beyond ISO 10993-18, including stricter testing requirements, the use of high-resolution mass spectrometry, triplicate batch testing, and detailed toxicological evaluations. Whether you're preparing for FDA submission or just trying to keep up with the evolving landscape of biocompatibility and extractables/leachables testing, this episode is packed with helpful information and practical advice from one of the leading voices in the field.
Episode 56: "IEC 81001-5-1" with Nick Thomas
29 April 2025
Episode #55 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield welcomes cybersecurity expert Nick Thomas from Intertek EWA Canada to break down what medical device manufacturers need to know about IEC 81001-5-1. From the similarities with IEC 62443 to tips on process evaluations, Nick shares real-world insights from recent projects and clears up common misunderstandings about cybersecurity conformance. Learn what it takes to build secure development life cycles, how to handle security testing, and why the IEC 81001-5-1 standard matters more than ever. Tune in and get ahead of the curve in medical device cybersecurity!
Episode 55: "California Prop 65" with Nick Jermstad
01 April 2025
Episode #55 of "Medical Compliance With Clarissa". In this latest episode, host Clarissa Benfield welcomes Intertek's Senior Director of Toxicology, Nick Jermstad, to explore California Prop 65 and its crucial impact on medical device manufacturers. Learn what Prop 65 is, how it specifically affects medical devices, and why no product—even FDA-approved medical equipment—is exempt. Nick shares key insights on navigating safe harbor limits, avoiding compliance pitfalls, and effectively managing regulatory risks. Tune in to understand how proactive compliance with Prop 65 can protect your products, brand, and customers in California and beyond.
Episode 54: "Ingress Protection (IP) Testing" with Samantha Doshi
18 March 2025
Episode #54 of "Medical Compliance With Clarissa". How well do medical devices hold up against dust, water, and other environmental factors? In this episode, Clarissa Benfield sits down with Samantha Doshi, Engineering Manager at Intertek, to break down Ingress Protection (IP) testing and why it’s crucial for medical devices. They discuss IP ratings, testing methods, and real-world considerations for ensuring device safety and reliability in hospitals, home healthcare, and beyond. Learn how manufacturers can navigate regulatory requirements and design products that withstand their intended environments. Listen in to learn more.
Episode 53: "Development of IEC 60601-1 4th Edition" with Yaqing Liu
05 March 2025
Episode #53 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield welcomes back Yiqing Liu, Intertek’s Medical Chief Engineer, to discuss the upcoming 4th edition of IEC 60601. They explore why a new edition is necessary after nearly 20 years, incorporating advancements in AI, machine learning, and cybersecurity. Yaqing provides insights into the timeline for publication, expected in 2029, and key changes such as integrating collateral standards, simplifying requirements, and moving towards a database-driven standard for customized compliance. They emphasize the importance of industry participation in shaping the standard for global harmonization.
Episode 52: "Digital Health & Advanced Tech" with Zaneer Iqbal
12 February 2025
Episode #52 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield, is joined by Zaneer Iqbal, Director of West Coast Operations, Intertek, to discuss advancements in digital health. They explore some key takeaways from the Digital Health Summit at CES 2025, focusing on wearable technology as well as how AI is revolutionizing real-time health monitoring, improving patient outcomes, and enhancing provider efficiency. With advancements in predictive analytics and personalized medicine, AI-driven solutions are set to transform the medical industry, despite some hurdles in adoption and standardization.
Episode 51: "Updates on IMDRF" with Christine Forcier
28 January 2025
Episode #51 of "Medical Compliance With Clarissa". In this episode, Clarissa Benfield and her guest, Christine Forcier, Global Program Manager for Medical Devices at Intertek Business Assurance, talk about updates to the International Medical Device Regulators Forum (IMDRF). They discuss its role in harmonizing global medical device regulations, its achievements like the Medical Device Single Audit Program (MDSAP), and its focus on emerging technologies such as AI and software. The episode highlights IMDRF's collaborative efforts, reliance principles, and exciting new developments, including upcoming meetings hosted by Japan in 2025.
Episode 50: Recap from Medica 2024
09 January 2025
Episode #50 of "Medical Compliance With Clarissa". This episode is another Special Report: a review of Medica 2024 in Düsseldorf, Germany. Intertek’s team was on-site exhibiting, meeting with medical device manufacturers, and discussing the latest trends in the industry. In this video we share some of the insights from our team, including thoughts on sustainability, surgical robots, wearables, software as a medical device (SaMD), AI-Enabled medical devices, and of course MDR. Watch this Special Report now to learn more!
Episode 49: "Updates to MDSAP" with Mia Spiegelman
07 January 2025
Episode #49 of "Medical Compliance With Clarissa". This episode features host Clarissa Benfield and her guest, Mia Spiegelman from Medtech Canada. Clarissa and Mia discuss MDSAP, the Medical Device Single Audit Program, and explore the program's benefits, industry challenges, and exciting future possibilities. Gain unique perspectives on harmonization, global access, why collaboration is key to innovation, and learn about what’s being done to ensure the program continues to improve and deliver value to the medical device industry.
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IEC 81001-5-1 and Cybersecurity for Medical Devices Webinar
Six Compliance-Related Questions About Connected Home Healthcare Devices
Accelerated Stress Testing for Medical Devices
Machine Learning and Artificial Intelligence (AI) in Medical Devices: Webinar | Fact Sheet
ENERGY STAR® Requirements for Medical Imaging Equipment
Creation of IEC 60601-1 4th Edition
IEC 60601-1-2 Ed. 4.1 Overview of Requirements
Medical OEM Wireless Coexistence Testing
Biocompatibility Risk Assessment and Evaluation Plans
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