Medical Podcast - Compliance with Clarissa

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.

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