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Author: Katrina Hurst, PhD





October 30, 2024

Documenting Device Changes in Biological Risk Assessments: Part Three

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...

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August 16, 2024

Documenting Device Changes in Biological Risk Assessments: Part Two

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.

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May 16, 2024

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...

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February 1, 2023

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...

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