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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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Knowledge Center
Download the latest information from our medical device compliance experts.
Accelerated Stress Testing for Medical Devices
Machine Learning and Artificial Intelligence (AI) in Medical Devices: Webinar | Fact Sheet
Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry
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
For more expert papers, recordings, and presentations, visit our Medical Resources hub.
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