FDA to use ISO 13485 for medical device quality

13th September 2018

To help streamline regulatory processes for medical devices across the world, the FDA has decided to replace its current system with ISO 13485, the organisation has announced.

Published in 2016, ISO 13485 is the international standard for quality management systems for the medical device sector. The regulation is designed to work efficiently and transparently with other management systems across the world.

The FDA’s decision to use ISO 13485 is another step in helping the standard gain global recognition.

Read more

  • Share:

Sign Up to receive our newsletter

© Medilink WM. All rights reserved.

Created by Gritt and Co