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Whitepaper

WHITEPAPER

Guidance on Combining Biocompatibility and Cleaning Validation Testing

Depending on the type and duration of contact for reusable devices, biocompatibility testing can involve more than ten endpoints that need to be addressed for first-time use and end-of-life use. This can be costly and time consuming.

Read this whitepaper to learn about the different factors and approaches to be considered for both the biocompatibility and reprocessing of reusable devices.

Learn more about the authors below.

Katrina (Katy) 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...

Jeralyn Franson

Jeralyn Franson

Senior Technical Writer

Jeralyn has been with Expert Advisory Services at Nelson Labs for over 3 years, during which time she has been responsible for writing healthcare reprocessing assessments/justifications/deliverables and has supported the preparation of toxicological risk assessment and biocompatibility evaluations. She received her MS degree in microbiology and molecular biology from Brigham Young University.

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