Considerations for Your Device’s Manual and Mechanical Cleaning Validations

Proper cleaning protocols for reusable medical devices have become a major focus in light of the recent superbug outbreaks associated with improperly cleaned duodenoscopes. Orthopedic OEMs need to validate either a manual or mechanical cleaning process (savvy manufacturers do both) when seeking FDA 510(k) clearance.

The Basics: Understanding the Medical Device Single Audit Program

MDSAP was launched to leverage resources of regulatory bodies in the U.S., Canada, Brazil and Australia to monitor device manufacturers. Here is a breakdown of how the pilot program works and each country’s participation.