An ever-evolving regulatory landscape, combined with increasingly complex and diverse medical devices, has challenged the testing protocols for many medical device manufacturers (MDMs). More companies want improved validation and accreditation processes, especially for pre-clinical device safety testing. Validation of cleaning, disinfection, and sterilization processes for many medical devices is already an ongoing improvement process. In addition, biocompatibility requirements are updated so frequently that it is hard for MDMs and their contract manufacturers (CMs) to keep up.
Author: Mark Crawford
