Medical Podcast - Compliance with Clarissa

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.

Episode 31: "PFAS in Medical Devices" with Matt Quinn
19 December 2023

Episode #31 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield welcomes back Matt Quinn to the podcast. Matt is a Director with Intertek Assuris and joined us in Episode #5 to talk about Hazardous Chemical compliance. This time Clarissa and Matt discuss per- and polyfluoroalkyl substances, also known as “PFAS”, also known as “Forever Chemicals” that are found in products people use every day, including medical devices. PFAS are chemicals used to make coatings that can improve the quality and performance of the products, but they have a downside. Some are toxic to our health, and they don’t degrade in water or in our bodies, and therefore just continue to leak out toxins. Clarissa and Matt discuss where PFAS are found in med devices, and what can be done to minimize the hazards.

Episode 30: "Defining a Medical Device and Essential Performance" with Nirav Darji
28 November 2023

Episode #30 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield talks to Nirav Darji, Sales Manager with Intertek’s Medical and Laboratory business in Germany, about what defines a Medical Device (as opposed to Laboratory equipment or other devices). Nirav explains that the key is in the manufacturer’s intended use of the product. They also dive into “Essential Performance” for medical devices, what it means, and how to test that a device will perform as intended.

Episode 29: "Satellite Data Acceptance" with Tom Van Luven
09 November 2023

Episode #29 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield chats with Tom Van Luven, Director of Intertek’s Satellite Data Acceptance Program. Data Acceptance programs have been used by manufacturers for decades to help them save time and money with compliance. In recent years it has become more popular with medical device and laboratory equipment manufacturers. Tune in to hear Clarissa and Tom discuss the benefits of the Satellite Program and who would be an ideal candidate to take advantage of such a program.

Episode 28: "SaMD" with Cyrus Ahmadi
31 October 2023

Episode #28 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield talks to Cyrus Ahmadi, a Consulting Engineer with Intertek’s Electrical Assurance team, about Software as a Medical Device (SaMD). This has really emerged the last few years and now warrants its own set of safety and performance requirements. Clarissa and Cyrus discuss what SaMD is, how it differs from Software in a Medical Device (SiMD), what those new compliance requirements are, and how they can be met confidently and efficiency.

Episode 27: "UKCA for Medical Devices" with Sharmila Gardner
17 October 2023

Episode #27 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield chats with Sharmila Gardner, Head of the UK Approved Body within Intertek’s Medical Notified Body. Intertek has now received formal designation as a UK Approved Body – a very exciting achievement – and Sharmila joins the podcast to talk about what this means, what’s different between UKCA and CE, what is now required for med devices in England, Scotland and Wales, what are the timelines, and much more.

Episode 26: "Cybersecurity By Design" with Wayne Stewart
03 October 2023

Episode #26 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield discusses Cybersecurity in medical devices (a popular topic!) with Wayne Stewart, Vice President of Intertek EWA-Canada. The goal that Wayne talks about for every manufacturer or healthcare facility is to plan and prepare for cybersecurity from the start. If the product is "secure by design" it's going to be better off, as opposed to trying to plug-in cybersecurity controls after the product design is set.

Episode 25: "Intertek in the Med Device Industry" with Sunny Rai
07 September 2024

Episode #25 of "Medical Compliance With Clarissa". In this special episode, host Clarissa Benfield talks to Sunny Rai, the president of Intertek's global Electrical, Transportation, and Connected World businesses. They discuss some of the changes in medical technology through the years, including the rapid "electrification" of the world, and how that improves product functionality and patient outcomes but also creates risk that manufacturers must navigate. Sunny shares his insights on how Intertek is preparing to meet the needs of manufacturers long-term, and how a risk-based approach to product design, quality, and compliance enables a safer world for everyone.

Episode 24: “Volatile Organic Compounds (VOCs)” with Kyle Tanis
24 August 2023

Episode #24 of "Medical Compliance With Clarissa". In this episode, Clarissa Benfield hosts Kyle Tanis, a Staff Scientist at Intertek's Kentwood (Grand Rapids) Michigan lab. Kyle has expertise testing products for Volatile Organic Compounds (VOCs) and providing manufacturers with critical data they need to ensure safety and compliance of their products. More recently Kyle has been focused on VOCs in medical devices as customer demand for this testing (along with biocompatibility testing and materials testing in general) has become a hot topic. Clarissa and Kyle explore a wide range of questions and topics about VOCs, from what they are and where they come from, to what impact do VOCs potentially have on the performance of a medical device.

Episode 23: “Product Certification” with Matt Snyder
09 August 2023

Episode #23 of "Medical Compliance With Clarissa". In this episode, Clarissa Benfield hosts Matt Snyder, Intertek's Sr. Director of Global ETL Certification. Matt has more than 20 years of experience in the product compliance industry and helps manufacturers worldwide gain the certifications they need in order to maximize their revenue potential. The discussion includes notification of standard updates, meeting OSHA requirements (as well as FDA requirements), refurbished medical devices, counterfeit certifications, surveillance inspections, and much more.

Episode 22: “Market Entry Into Brazil” with Amanda Strumiello
18 July 2023

Episode #22 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield talks to Amanda Strumiello, Intertek's Business Line Manager for Electrical and Hardlines products in Brazil. Amanda has in-depth expertise in helping medical device manufacturers meet market entry requirements such as INMETRO for the growing Brazil market. Did you know that as long as your testing is done at an ILAC-accredited lab you DO NOT need to have retesting done in-country in Brazil? That's great news for Intertek clients! Listen in to Clarissa's and Amanda's conversation for more great info about Brazil market requirements.

Episode 21: “Cybersecurity for Med Device Update” with George Strom
29 June 2023

Episode #21 of "Medical Compliance With Clarissa". In this episode, host Clarissa Benfield welcomes back George Strom from Intertek's Connected World team to talk about updates in Cybersecurity requirements. In more regions of the world, cybersecurity is no longer a nice-to-have but rather a requirement of the responsible government agencies. George and Clarissa discuss the FDA's new "right of refusal" pertaining to medical devices beginning October 1, 2023, as well as regulator updates in the EU, Japan, and elsewhere.

Episode 20: “How To Best Prepare For Medical Device Testing” with Andrew Hyatt
14 June 2023

Episode #20 of "Medical Compliance With Clarissa" features guest Andrew Hyatt, Sales & Operations Director of Intertek's Medical Device Testing Center of Excellence in Boxborough, Massachusetts. In this episode, Clarissa and Andrew discuss some of the best and most efficient ways to prepare for your compliance project, including sample prep, documentation, checklists, opportunities for concurrent testing, and other items that can keep your project on track. Andrew also highlights some of innovative technology he's seeing in the lab and how Intertek is constantly looking to stay in-step with the speed of innovation from our clients.

Episode 19: “EU Medical Device Regulation (MDR)” with Martin Lindvall
10 May 2023

Episode #19 of "Medical Compliance With Clarissa" features guest Martin Lindvall, the Technical Planning Team Leader at Intertek's Medical Notified Body in Sweden. The discussion begins with a quick recap of the transition from the EU's Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). It then leads into hot topics such as the need for clinical evidence, the new extension deadlines, how to choose a Notified Body, how to best prepare your submission, and more.

Episode 18: “Intertek’s Medical Accreditations” with Paul Moliski
25 April 2023

Episode #18 of "Medical Compliance With Clarissa" features guest Paul Moliski, Intertek's Vice President of Accreditations. Paul spearheads the application process and maintenance for accreditations of Intertek's Electrical laboratories globally, and he was instrumental in obtaining FDA ASCA accreditation very early in the program's pilot status. As of this podcast release in April 2023, Intertek has 16 ASCA-accredited labs around the world to help medical device manufacturers take advantage of this potentially time- and cost-saving program.

Episode 17: “In-Vitro Diagnostics Compliance” with Claudia Sirch
11 April 2023

Episode #17 of "Medical Compliance With Clarissa" features guest Claudia Sirch, Intertek's ECA Region Chief Electrical Engineer, for an in-depth discussion of In-Vitro Diagnostics (IVD) Equipment compliance. Claudia talks about the increase in new types of IVD equipment since the pandemic, what manufacturers need to keep in mind for compliance, how to select the appropriate standard for testing, and much more.

Episode 16: “NMPA Process & Exporting Medical Devices to China” with Yaqing Liu
22 March 2023

Episode #16 of "Medical Compliance With Clarissa" features guest Yaqing Liu, Intertek's global chief medical engineer. Yaqing is an expert in many areas of medical device testing and compliance, but being originally from China she is especially close to (and passionate about) the NMPA's new Self Testing program for medical devices. Host Clarissa Benfield and Yaqing talk about the processes, the timeline, and how manufacturers can now export their medical devices to China faster and more efficiently than ever.

Episode 15 : “Evolution of Home Healthcare & Medical Device Compliance” with Scott Blue
02 March 2023

Episode #15 of "Medical Compliance With Clarissa" features guest Scott Blue. Scott is a Senior Director of Operations and Sales at Intertek and leads the outstanding medical laboratory in Fridley, Minnesota. In this episode Clarissa and Scott discuss the impact of the fast-growing Home Healthcare market for medical devices, including the types of products that we're starting to see in the lab as well as the wide range of tests that need to be conducted in order to show compliance for a home environment versus a professional healthcare setting.

Episode 14: “The Benefits of Performance Testing” with Alex Porter
09 February 2023

Episode 14 of "Medical Compliance With Clarissa" welcomes Intertek Global Director of Engineering, Alex Porter. Clarissa and Alex discuss a variety of different types of performance tests that a medical device manufacturer should conduct in order to validate assumptions made during the product design phase. It's much less expensive to discover potential failure points in the lab than to discover them once the product is already on market.

Episode 13: “Compliance FAQs for Medical Technical Lead” with Jenny Larsson Falk
24 January 2023

Episode #13 of "Medical Compliance With Clarissa" features guest Jenny Larsson Falk, our Technical Lead for Medical Devices at Intertek Sweden. For more than a decade Jenny has helped device manufacturers conduct testing to meet regulatory compliance. She has answered a lot of questions and gained a world-class level of expertise. In this episode Jenny answers questions regarding critical components, fire protection, sample requirements, applied parts vs. accessible parts, and finally one of the most common topics she receives questions on… essential performance.

Episode 12: "Medical Device Single Audit Program (MDSAP)" with Christine Forcier
12 January 2023

Episode #12 of "Medical Compliance With Clarissa" features guest Christine Forcier, the global medical program manager for Intertek's Business Assurance team. Christine and Clarissa discuss the MDSAP program for ISO 13485 and the benefits of using a single audit program for quality management system requirements covering multiple countries (US, Canada, Brazil, Australia, and Japan). Medical device manufacturers can use this program for greater efficiency when launching new devices.

Episode 11: “Medical Safety 60601-1 3.2” with Joel Smith
12 December 2022

Episode #11 of "Medical Compliance With Clarissa" features guest Joel Smith - a Senior Project Engineer on Intertek's Medical team in Boxborough, MA. Joel has nearly two decades of experience working with medical device manufacturers regarding their compliance and especially their safety compliance to the latest 60601-1 family of standards. In this episode, Joel discusses the evolution of the safety standard, changes to the Risk Management process, and the three key things you need to think about: the documentation requirements, the construction requirements, and electrical and mechanical safety testing requirements.

Episode 10: “FDA 510k Submission Consulting” with Bhavesh Sheth
15 November 2022

Episode #10 of "Medical Compliance With Clarissa" features guest Bhavesh Sheth, a Senior Consultant with Intertek's Medical Assurance team. Bhavesh is an expert in helping medical device manufacturers plan and develop an FDA 510k Submission for their products. He has been an FDA-accredited third-party reviewer and has decades of experience working with device manufacturers around the world in preparing their products for regulatory compliance and ultimately successful launch to market. Tune in to hear his thoughts and suggestions on the evolving FDA submission process.

Episode 9: “Batteries and Energy Storage in Medical Devices” with Rich Byczek
01 November 2022

Episode #9 of "Medical Compliance With Clarissa" features guest Rich Byczek, Intertek's Global Technical Director for Energy Storage. As practical usage for portable medical devices increases, so does the need for well-planned energy storage and batteries in the design. Different applications might require different types of chemistries (lithium, lithium ion, alkaline) and compliance requirements can differ between them. Shipping and storage also need to be considered when choosing different batteries. Clarissa and Rich discuss all these options.

Episode 8: "Evolving Needs Of Device Manufacturers" with Ray Payne
19 October 2022

Episode #8 of "Medical Compliance With Clarissa" features guest Ray Payne, Regional Sales Manager in Boxborough, Massachusetts, one of Intertek's medical centers of excellence. Ray has worked with hundreds of medical device manufacturers during the last 10+ years and has seen their compliance needs evolve during that time, from regulatory compliance to design challenges to supply chain issues to keeping up with FDA requirements.

Episode 7: “Medical Robots” with Bill Stearns
04 October 2022

Episode #7 of "Medical Compliance With Clarissa" features guest Bill Stearns, Intertek's Lead Engineer for Medical Robots and Robotics. Bill sees some of the most advanced medical technology in the world and in this exciting episode he shares with Clarissa his thoughts on where Medical Robots are today, where they are going in the future, and how safety, EMC, and performance requirements play a critical role in gaining approval from the FDA and other agencies.

Episode 6: “Compliance of Wireless Medical Devices” with Ollie Moyrong
20 September 2022

Episode #6 of "Medical Compliance With Clarissa" features guest Ollie Moyrong, EMC Manager at Intertek's Menlo Park, CA laboratory. Ollie is widely recognized throughout the industry as an expert in EMC and radio/wireless compliance and sits on technical committees that help shape these standards. In this episode he discusses requirements for wireless medical devices, including IEC 60601-1-2, plus additional co-existence testing requirements for products that use wifi, bluetooth, bluetooth low energy, etc.

Episode 5: "Hazardous Chemical Compliance" with Matt Quinn
06 September 2022

Episode #5 of "Medical Compliance With Clarissa" features guest Matt Quinn, Director, Intertek Assuris. Matt has extensive expertise in Health & Environmental regulations and has worked with manufacturers for nearly two decades to ensure compliance throughout the value chain and of course the end-product. Tune in to learn more about the emerging role of Risk Assessment and Risk Management for hazardous chemicals.

Episode 4: "Questions About FDA and MDR" with Chris Wyman
23 August 2022

Episode #4 of "Medical Compliance With Clarissa" featuring guest Chris Wyman, Intertek's Medical Director in North America. Chris has nearly 20 years of experience working directly with medical device manufacturers to meet compliance requirements of various agencies and authorities around the world. Today Chris talks about some of the most common questions he's hearing about the FDA and the Medical Device Regulation (MDR) in Europe.

Episode 3: "Cyber Security For Medical Devices", with George Strom
09 August 2022

Episode #3 of "Medical Compliance With Clarissa" featuring guest George Strom, Intertek's IoT Business Development Director. George has worked with manufacturers for 25 years helping them meet compliance and regulatory requirements. Now he's one of Intertek's top experts in Cyber Security compliance helping companies address the threats and vulnerabilities that arise from "connected devices".

Episode 2: "FDA Guidance On Medical EMC", with Nicholas Abbondante
27 July 2022

Episode #2 of "Medical Compliance With Clarissa" featuring guest Nicholas (Nick) Abbondante, Intertek's global chief engineer for EMC. Nick was originally going to join to talk about general EMC requirements for medical devices but dropped some hot info on us related to a new FDA Guidance Document that was released in June 2022 that has an August 2022 effective date. You don't want to miss this information!

Episode 1: "Risk Assessments", with Mike Brousseau
13 July 2022

Episode #1 of "Medical Compliance With Clarissa" featuring guest Mike Brousseau, Intertek's regional chief engineer for medical devices. Clarissa and Mike cover a lot of ground but really dig in on Risk Assessments and the evolution of medical device compliance from simply testing to a standard to now being more thoughtful and comprehensive of all potential risks the product, users, and patients could face.