The EU is conditionally extending the MDR deadline. Medical device manufacturers with certificates approved before 26 May 2021 can extend their validity if their products meet certain conditions, one of which is the establishment of an MDR-compliant Quality Management System (QMS).
As a company, SAXOCON is ISO 13485 certified. We also have BSI-certified ISO 13485 internal auditors who can help you implement your QMS, allowing you to keep your current certification and prepare for the upcoming changes to MDR.
Read more to see how we can help you navigate this complex regulatory maze.