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).
July 15, 2021
By: Lise Vanderkelen and Alpa Patel
Initial rinse The first step in the cleaning process is often a rinse with cool utility water to remove any...
July 8, 2021
Validating a cleaning procedure starts with selecting an appropriate artificial test soil that is representative of the worst-case challenges that...
July 7, 2021
By: Lise Vanderkelen
Getting a fever, is something that all of us have experienced. However, when we use medicines or medical devices, we...
July 2, 2021
Simulated use is defined as “use that mimics the intended use of the medical device”[1]. In guidance documents such as...
June 25, 2021
Instructions for use (IFU) documents can come in many different shapes and sizes and looking at these documents, the term...