The EU is conditionally extending the MDR deadline. If you are a medical device manufacturer with a certificate approved before 26 May 2021, you can extend its validity if your product meets the set conditions. One of these conditions is establishing an MDR-compliant quality management system.
As a company, SAXOCON is ISO 13485 certified. We also have BSI-certified ISO 13485 internal auditors who can help you get your QMS up and running, allowing you to keep your current certification and prepare for the coming MDR changes.