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

On-Demand Webinars

Learn from our experts on industry topics.

ISO 10993-1: a matchmaker guide for a biologically safe relationship between a medical device and a patient

How to evaluate a potential biologically safe relationship between a medical device and a patient, is a challenging question that...

Introduction to Sotera Health

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare...

Webinar: Impact of Device Changes on Biocompatibility

Change is the one constant in life and that is absolutely the current climate in the medical device industry. This...

Preparing a Device Master Record (DMR)

Ensuring compliance looks different depending on what phase you’re in (e.g., pre-market, post-market, or somewhere in between). In this webinar, one...

Bioburden Testing and Microorganism Characterization: Enhanced Guidance for Low-Sterilization-Dose Products

In recent years some concerns have been raised regarding the lack of understanding of bioburden—numbers as well as types of...