ISO 13485

Medical devices

Standard ISO 13485

People concerned

All suppliers, subcontractors of products or services related to medical devices.

All manufacturers marketing medical devices, in accordance with european directives on medical devices and in vitro diagnostic devices

Audit team

Auditor or auditing team with proven experience in themedical devices sector and associated european directives and qualified under the new accreditation rules on their skills.


The certification is obligatory for certain classes of medical devices for initial release on the European market. They are in this case complementary to CE marking.