The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
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...
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.
“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...
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...
