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Welcome to the RA QA Café

Operating room with monitor

Published:

February 8, 2023

BiocompCHATibility

A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.

In this first BiocompCHATibility Podcast episode of 2023, our hosts are happy to introduce a new podcast to the NAMSA family, and talk a little bit to the hosts about the insightful topics to come.

This new, conversational podcast will feature a new set of hosts who dedicate each episode to trending regulatory and quality affairs topics within the MedTech industry.

Future topics include:

  • Refuse to Accept Policy for 510(k)s – This episode will delve into the procedures and criteria FDA intends to use in assessing whether a premarket notification (510(k)) submission meets a minimum threshold of acceptability and if it should be accepted for substantive review.
  • FDA Releases Draft Guidance: Content of Premarket Submissions for Device Software Functions – As a follow-up to one of NAMSA’s recent blog posts, our hosts will describe information that the FDA deems important during its evaluation of the safety and effectiveness of device software with one or more device functions.
  • Compliance Pitfalls (Start-up Focus) – This episode will focus on common compliance obstacles faced when dealing with documenting procedures, complaint handling processes, supplier controls, audit & training, laboratory controls, monitoring and calibration and more.

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Also be sure to check out our Biocompatibility Strategy Navigator.

Richard M. Granquist

Richard M. Granquist

In 2014, Rich joined NAMSA as a Quality Systems Consultant and has now been with the company for eight years. Over his 16 years in the industry, he has participated in numerous AAMI ISO standards committees and currently sits on the committees for ISO 14971, ISO 13485 and ISO 15223. Rich’s medical device industry experience also includes extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management. Rich started in the medical device industry as a Microbiologist focusing on aseptic technique and terminal sterilization at Cook Medical. During his 8-year career at Cook, he expanded his responsibilities to include coordination of preclinical testing, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices.

Sheri Krajewski

Sheri Krajewski

Sheri joined NAMSA in 2003 and currently serves as Senior Global Product Marketing Manager of Biological Safety. Sheri has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s Biological Safety Consulting business. Additionally, she created the much sought-after NAMSA Training Series (NTS) for the iological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Linford Leitch

Linford Leitch

In 2021, Linford joined NAMSA as a Regulatory Consultant. He has 9 years of experience in the medical device industry with direct regulatory experience with Spine, Transcatheter Heart Valves and Hemodialysis devices. He specializes in developing global regulatory strategies for entry to market and maintain strategies throughout product lifecycle.

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