Medical Podcast - Compliance with Clarissa

03 October 2023

Episode 26 - Cybersecurity By Design with Wayne Stewart

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.

07 September 2024

Episode 25 - Intertek in the Med Device Industry with Sunny Rai

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.

24 August 2023

Episode 24 – “Volatile Organic Compounds (VOCs) with Kyle Tanis”

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.

09 August 2023

Episode 23 – “Product Certification with Matt Snyder”

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.

18 July 2023

Episode 22 – “Market Entry Into Brazil with Amanda Strumiello”

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.

29 June 2023

Episode 21 – “Cybersecurity for Med Device Update with George Strom”

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.

14 June 2023

Episode 20 – “How To Best Prepare For Medical Device Testing with Andrew Hyatt”

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.

10 May 2023

Episode 19 – “EU Medical Device Regulation (MDR) with Martin Lindvall”

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.

25 April 2023

Episode 18 – “Intertek’s Medical Accreditations with Paul Moliski”

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.

11 April 2023

Episode 17 – “In-Vitro Diagnostics Compliance with Claudia Sirch”

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.

22 March 2023

Episode 16 – “NMPA Process & Exporting Medical Devices to China” with Yaqing Liu

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.

2 March 2023

Episode 15 – “Evolution of Home Healthcare & Medical Device Compliance” with Scott Blue

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.

9 February 2023

Episode 14 – “The Benefits of Performance Testing” with Alex Porter

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.

24 January 2023

Episode 13 – “Compliance FAQs for Medical Technical Lead” with Jenny Larsson Falk

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.

12 January 2023

Episode 12 - "Medical Device Single Audit Program (MDSAP)" with Christine Forcier

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.

12 December 2022

Episode 11 – “Medical Safety 60601-1 3.2” with Joel Smith

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.

15 November 2022

Episode 10 – “FDA 510k Submission Consulting” with Bhavesh Sheth

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.

1 November 2022

Episode 9 – “Batteries and Energy Storage in Medical Devices” with Rich Byczek

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.

19 October 2022

Episode 8 – “Evolving Needs Of Device Manufacturers” with Ray Payne

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.

04 October 2022

Episode 7 – “Medical Robots” with Bill Stearns

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.

20 September 2022

Episode 6 – “Compliance of Wireless Medical Devices” with Ollie Moyrong

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.

06 September 2022

Episode 5 - "Hazardous Chemical Compliance" with Matt Quinn

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.

23 August 2022

Episode 4 - "Questions About FDA and MDR" with Chris Wyman

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.

09 August 2022

Episode 3 - "Cyber Security For Medical Devices", with George Strom

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".

27 July 2022

Episode 2 - "FDA Guidance On Medical EMC", with Nicholas Abbondante

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!

13 July 2022

Episode 1 - "Risk Assessments", with Mike Brousseau

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.