Deutsch|   Englisch

QM Certification

Also in the area of in vitro diagnostic devices the voluntary certification according to QM standards is of particular interest. Manufacturers of devices which are not subject to Notified Body certification receive, during a procedure according to EN ISO 13485, a judgment whether their quality is compliant in the light of Directive 98/79/EC and the respective national law.

As well as in the area of medical devices for subcontractors and suppliers of components and semi-finished products a certificate according to EN ISO 13485, issued by a registrar, who is recognized as a Notified Body, is a real benefit.

Beside the fact, that manufacturers usually consider the availability of a certificate according to EN ISO 13485 as evident, also the frequency of suppliers audits performed by their Notified Bodies decreases significantly.