This whitepaper, the second in a four-part series covering different examples of device changes to be documented in biological risk assessments, discusses the scenario of a change to a material supplier and manufacturing site.
Whitepaper
WHITEPAPER
Documenting Device Changes in Biological Risk Assessments: Part Two
August 16, 2024 | By: Katrina Hurst, PhD
Katrina (Katy) Hurst, PhD
Biocompatibility Expert
Katrina (Katy) Hurst is an expert in biocompatibility, especially with respect to the relationship between medical device materials, biological systems, and the analytical procedures used to evaluate biocompatibility in vitro and in vivo. Katy has extensive expertise in writing biological evaluations and assessments for regulatory submissions. She also has over ten years of experience in...
