EN ISO 13485:2016 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices and therefore plays an important role, especially for the medical technology industry. 

As part of a surveillance audit, STERISYS was audited for compliance with the standard by TÜV Rheinland on April 27-28. Thus, the existing EN ISO 134885:2016 certificate was confirmed with "no findings" for another year.

If you have any further questions on this subject, we look forward to hearing from you.