October 30, 2024 | By: Katrina Hurst, PhD
This is the third whitepaper in a four-part series covering different examples of how to document device changes in biological risk assessments. This whitepaper discusses the scenario of a change to a contract sterilizer, sterilization site, and cycle parameters.
Learn more about the author below.
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...
