Reprocessing Medical Device FDA / MDR Readiness

Validated Reprocessing for Patient Safety and Compliance

Processing / Reprocessing of medical devices is essential to ensure that reusable instruments are free from contamination before each use, eliminating any risk of infection for patients. Regulations and standards such as the EU Medical Device Regulation (MDR 2017/745), ISO 17664, FDA’s Reprocessing of Reusable Medical Devices guidance as well as ANSI/AAMI ST98 require manufacturers to provide a validated processing / reprocessing procedure, ensuring patient safety and full compliance.