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.
Features
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.
Range of offer
Certifications
Area of professional activity
EQS certifications - since 1990
EURO-QUALITY SYSTEM
14, Avenue de l’Europe
Regus - Etage 3
77144 Montévrain
FRANCE
Tel : 00 33 160 428 948
