Medical Podcast - Compliance with Clarissa

Episode 47 - Wireless Coexistence Testing for Medical Devices
17 November 2024

Episode #47 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield and Brian Lackey, EMC Staff Engineer at Intertek, discuss the critical role of wireless coexistence testing for medical devices. They cover how wireless interference can impact device performance, especially with the rise of connected devices. The FDA's guidelines are emphasized, particularly the importance of assessing devices' functionality in both professional and home environments with potential interference sources. They also outline risk-based testing tiers and practical strategies for manufacturers to ensure device reliability amid wireless challenges.

Episode 46: Recap from AdvaMed MedTech Conference 2024
01 November 2024

Episode #46 of "Medical Compliance With Clarissa". Host Clarissa Benfield shares a recap of the AdvaMed MedTech Conference 2024 with interviews from some of the Intertek team members who were at the conference. The discussion focuses on trends that were noticed at this year’s show, plus reactions to the many interesting sessions available throughout the three days. Tune in to get the team’s insights and to hear what they found most interesting at this year’s event.

Episode 45: Industry Trends In Compliance with Rachel Robinson
08 October 2024

Episode #45 of "Medical Compliance With Clarissa". Host Clarissa Benfield and Rachel Robinson, Chief Operating Officer at MassMEDIC, dive into some medical device industry trends related to compliance. Manufacturers in the medical device industry are increasingly focusing on regulatory compliance earlier in the design process. This shift, which began around 2009-2010, is driven by the need to de-risk products for investors and acquirers, enhance quality control, and streamline time-to-market. Previously, many companies retrofitted compliance later in development, but as regulatory requirements have become more complex, early-stage planning is critical.

Episode 44: Medical Photobiological Equipment with Nicolas Manders
18 September 2024

Episode #44 of "Medical Compliance With Clarissa". Host Clarissa Benfield speaks to Nicolas Manders, a Senior Project Engineer in Intertek’s Lake Forest, CA lab, about the challenges related to the quality, safety, and performance of medical photobiological devices, particularly light therapy equipment. They explore the complexities of ensuring safe home use of these devices, the role of risk management, and the importance of meeting stringent standards like IEC 62471 and IEC 60601-2-83. They also address common hurdles for manufacturers, especially those transitioning from non-medical sectors, in achieving compliance and certification for their products.

Episode 43: Lab & Life Science Equipment with Brett Gagnon
04 September 2024

Episode #43 of "Medical Compliance With Clarissa". In this episode, Clarissa Benfield hosts Brett Gagnon to discuss the complexities of regulatory compliance and product certification for electrical laboratory and life science equipment. Brett shares insights from his experience on both the testing and manufacturing sides, emphasizing the importance of early engagement with test labs, building strong partnerships, and the benefits of having a deep understanding of global standards. The discussion highlights strategies for navigating product compliance efficiently, including the significance of risk management and documentation best practices.

Episode 42: IEC 81001-5-1 Cybersecurity with Joe Dawson
20 August 2024

Episode #42 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield talks to Joe Dawson, Principal Software Security Analyst with Intertek's Connected World team, about the significance of the IEC 81001-5-1 standard, its impact on the industry, and practical insights for manufacturers aiming to ensure compliance and security. Discover how this important standard enhances software development processes, safeguards patient safety, and aligns with global regulatory expectations. Whether you're new to cybersecurity or looking to deepen your understanding, this conversation is a must-watch for medical device professionals.

Episode 41: 21 CFR 820 Amendment Ruling with Alexander Crosby
06 August 2024

Episode #41 of "Medical Compliance With Clarissa". In this episode Clarissa Benfield hosts Alexander Crosby, Americas Medical Program Director for Intertek Business Assurance, to discuss the final ruling on the 21 CFR 820 regulation, which will go into effect in February 2026. They dive into the FDA's decision to align with ISO 13485, reflecting a significant shift towards global harmonization and emphasizing the importance of quality management systems beyond mere compliance. Manufacturers are encouraged to begin preparations now to meet the new standards and ensure a smooth transition.

Episode 40: Unique Device Identification with Marco Fedeli
15 July 2024

Episode #40 of "Medical Compliance With Clarissa". In this episode Clarissa Benfield hosts Marco Fedeli, a consultant with Intertek’s Medical Assurance team, to talk about Unique Device Identification (UDI) of medical devices. UDIs are yet another required marking for medical devices. They must appear on the device itself and on every level of the device’s packaging. What are they? How does a manufacturer go about implementing them? Which countries/regions require them? Get all the answers to these questions and more by tuning in today.

Episode 39: MoIAT Requirements in the Middle East with Bruce McGill
25 June 2024

Episode #39 of "Medical Compliance With Clarissa". In this episode Clarissa Benfield hosts Bruce McGill, Global Vice President of Certification at Intertek, to talk about MoIAT (Ministry of Industry and Advanced Technology) Requirements for medical devices and instruments in the UAE. This new Cabinet Resolution covers the conformity requirements, the scope of products, and the methods of surveillance to control the program going forward.

Episode 38: Product Standards and Intertek Inform with Phil Kingham
03 June 2024

Episode #38 of "Medical Compliance With Clarissa". In this episode Clarissa Benfield hosts Phil Kingham, Commercial Director at Intertek Inform (formerly SAI Global Standards). The world of product standards, especially in the med device industry, is dynamic and always evolving. Understanding which standards apply for different markets can be a challenge. Phil provides some insights into this process, how to stay on top of changing standards (including some new AI solutions), and of course where to go when you’re ready to buy them. (www.intertekinform.com). We even get a special audio appearance by Phil’s baby for a minute. It’s a family-friendly episode!

Episode 37: MDR Deadlines & Schedule with Curtis Riley
07 May 2024

Episode #37 of "Medical Compliance With Clarissa". In this episode Clarissa Benfield hosts Curtis Riley, the head of Intertek’s Medical Notified Body (IMNB), to discuss the latest deadlines and the overall schedule for the Medical Device Regulation (MDR). The dates were extended in order to give industry and the Notified Bodies a realistic opportunity to ramp up, but now these deadlines are drawing closer and manufacturers must be ready to submit applications to a Notified Body. Tune in to get all the upcoming dates and requirements.

Episode 36: Med Device Industry Trends and Insights with Tom Salemi
24 April 2024

Episode #36 of "Medical Compliance With Clarissa". In this episode Clarissa Benfield hosts Tom Salemi, host of DeviceTalks podcasts and conferences, to get his insights on the med device industry today. Tom has his finger on the pulse of the industry, interviewing leaders from device manufacturers and key influencers, and shares some of his stories and where he sees the world of devices going, including surgical robotics, AI, and more. Tune in now to hear from one of the most plugged in personalities in the business.

Episode 35: FDA ASCA Program with Eric Franca
09 April 2024

Episode #35 of "Medical Compliance With Clarissa". In this episode Clarissa Benfield hosts Eric Franca, PhD, Director of the Conformity Assessment Program at the CDRH/FDA, to talk about the FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program. While it sounds like a mouthful, the ASCA program is actually an opportunity for medical device manufacturers to significantly reduce the complexity and turnaround time of their FDA submissions. Some manufacturers have already labeled it “a game-changer”. Listen now to hear ASCA is all about.

Episode 34: AI and Medical Devices with Mike Lynch
27 March 2024

Episode #34 of "Medical Compliance With Clarissa". In this episode, Clarissa Benfield and Intertek’s Principal Medical Consultant, Mike Lynch, dive head-first into a discussion on AI and Medical Devices. There’s currently a lot of work being done with image-based data (X-rays, MRI, CT) using AI, and the COVID pandemic accelerated its usage enabling healthcare providers to quickly triage patients. Its potential in medical diagnostics is just scratching the surface and the technology continues to improve every day. Hear more from Mike and Clarissa on how Artificial Intelligence is making an impact on medical devices.

Episode 33: "Sustainability of Med Devices" with Beth Mielbrecht
17 January 2024

Episode #33 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield talks to Beth Mielbrecht with Intertek Assuris about Sustainability of Medical Devices. It’s a topic many companies talk about yet still aren’t sure exactly what it means or what they should be doing. According to Beth there’s no one-size-fits-all solution and it’s primarily driven by your business goals. Manufacturers need to consider the product’s sustainability (both during use and end-of-life) as well as the organization’s sustainability (carbon footprint overall). With many medical devices now available direct to consumer, they may be making buying decisions based on the product’s or company’s sustainability profile. It’s a new era that manufacturers need to better understand. Get started today by tuning in to our podcast.

Episode 32: "Accessibility for Medical Devices" with Rachael Gill
08 January 2024

Episode #32 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield talks to Rachael Gill, a Design Researcher from Coventry University in the UK. In her research she helps designers recognize what people need and want in products, services, and systems they use. Rachael has worked with medical device manufacturers to understand how products can best meet patients’ needs, especially with accessibility challenges. She discusses the benefits of “co-design” where potential users are part of the design and development process from the beginning to ensure needs can be met. Usability and accessibility are critical topics in design and development today. Tune in now to hear Clarissa and Rachael’s conversation.