It’s no secret that an effective Quality Management System (QMS) is essential for compliance with the EU’s incoming Medical Device Regulation (MDR) as well as ISO 13485 certification.

First published in 2017, the EU’s Medical Device Regulation (MDR) became mandatory for medical device companies in 2021. However, there are still many devices on the market with MDD certificates. These will soon expire or require attention before 2024 – even with the planned extension to the MDR transition period.

It might be a voluntary certification for the quality management of medical devices, but ISO 13485 is considered by many to be the gold standard. In fact, as many medical device companies already know, obtaining this standard helps smooth the path to compliance with the European Union’s latest Medical Device Regulation.