Compliance Pitfalls of In Vivo Studies—How to Learn from the Mistakes of Others

Operating room with monitor

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RAQA Café

A podcast series that tackles trending Regulatory Affairs and Quality Affairs (RAQA) topics within the MedTech industry.


In our sixth episode of the NAMSA RAQA Café Podcast, we sit down with guest speaker Jack Risdahl, NAMSA Principal Product Development Strategist and Doctor of Veterinary Medicine.

During our discussion, Jack delves into common mistakes that are observed when conducting In Vivo studies, ways in which to mitigate these mistakes and variances pertaining to In Vivo study expectations in different global markets.

“We reach out to other experts and bounce ideas. Am I missing something based on your experience?” – Jack Risdahl (Principle Product Development Strategist)

Discussion topics include:

  • Institutional Animal Care and Use Committee (IACUC) and how a small company can navigate animal welfare requirements
  • How to engage with a cross-functional team to rectify mistakes
  • Study considerations and best practice for evaluations

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

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.

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.

Jack Risdahl, DVM, PhD

Jack Risdahl, DVM, PhD

Dr. Jack Risdahl has over 27 years of experience in medical research and in vivo laboratory medicine. He has held numerous medical research leadership positions in both academia and industry. His current responsibilities include working with sponsors to design Preclinical studies for new medical products that meet regulatory requirements worldwide. Prior to NAMSA, he co-founded the Integra Group Preclinical Services and acted as a managing partner. He has participated in numerous FDA meetings to discuss submission requirements, preclinical study design and interpretation of results. He has also been involved with several publications, including transplantation, inflammation, immunity, infectious diseases and medical devices. Dr. Risdahl holds two doctorate degrees in Veterinary Medicine (DVM, and Ph.D.).