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).
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...
September 15, 2021
ISO 17664[1] and ISO17664-2[2] clearly state that all reprocessing instructions provided in the Instructions For Use (IFU) document must be...
September 8, 2021
It is important that all reprocessing instructions included in the Instructions For Use document are validated to ensure patient safety...
