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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.

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.

Katrina Hurst, PhD

Katrina Hurst, PhD

Biocompatibility Expert

Katrina has extensive expertise writing biological evaluations and assessments for regulatory submissions. She also has over ten years of experience in scientific research, over four years of medical device experience managing validation work for regulatory acceptance, and is currently working as a biocompatibility expert in the technical consulting group at Nelson Labs, giving guidance and recommendations for biocompatibility assessments targeted for regulatory submissions all over the world. She received her PhD in physiology and developmental biology from Brigham Young University.

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