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Whitepaper

WHITEPAPER

Documenting Device Changes in Biological Risk Assessments: Part One

“Device changes can range in complexity, making it critical that each change be treated uniquely and assessed appropriately to ensure patient safety,” writes the author, Katrina Hurst, PhD (see a brief bio of her below). In this white paper she discusses different examples of device changes and how they should be effectively documented in a risk assessment.

 

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...

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