Guest
CE mark and ISO 13485 for medical device in EU
Is it necessary to be ISO 13485:2016 certified before pursuing the CE Marking? Or is having the ISO 13485 more of a benefit, and not a requirement.
Assign topic to the user
Expert
Verlene Law
Jan 02, 2019
Answer: In the EU context, the CE mark is part of the conformity assessment procedure, therefore, is actually a priority over ISO13485. Having ISO 13485 is more of a benefit.
As a company dealing with medical devices, being ISO13485 certified could provides an added assurance that the company has a quality management system in place that can ensure the quality, safety and performance of the devices as well as open up more opportunity for exporting of the products.
For more information, please refer to :
Six key benefits of ISO 13485 implementation
https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
Comment as guest or Sign in
Jan 02, 2019
Jan 02, 2019
Jan 02, 2019