Medical Podcast - Compliance with Clarissa

12 January 2023

Episode 12 - Medical Device Single Audit Program (MDSAP)

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.