Written by our experts, our blog provides updates on regulatory issues, upcoming changes to compendial test standards, and information about our participation with standard writing committees and organizations (AAMI, ASTM, AATB, ISO).
December 7, 2021
By: Lise Vanderkelen and Alpa Patel
Understanding the sterility assurance level To understand how steam sterilization processes are validated, it is important to understand some key...
November 30, 2021
ISO 17664:2017[1] as well as FDA[2] state that if a medical device is intended to be sterilized, at least one...
November 18, 2021
By: Jennifer Gygi and Maria Thomas
Particulate testing is required for medical devices to ensure patient safety, but there isn’t a lot of guidance available. Here...
October 14, 2021
By: Lee Wence PhD
While you may not want to think of the words “worst case” relating to your product, these words are critical...
September 28, 2021
By: Alpa Patel and Lise Vanderkelen
The FDA guidance on reprocessing medical devices in health care settings: validation methods and labeling states, that when performing cleaning...
