For legal manufacturers of in vitro diagnostic devices we offer conformity assessment procedures according to Directive 98/79/EC as a Notified Body (EU Identification Number „0483“).Conformity assessment with the involvement of a Notified Body is mandatory for all manufacturers of products according to Annex II list A and B, as well as, for self testing products by lay users.
Our main activities in this area are not only on-site audits of the quality system for manufacturers and their subcontractors, but also the assessment of Technical Files of the respective products as well.
For this activity we provide beside our trained auditors a range of experts experienced for years in industry, research institutions, laboratories or at Notified Bodies. For the verification of manufactured products in the area of high-risk devices according to Directive 98/79/EC, List A we have a well-established cooperation with the test laboratory for in vitro diagnostic devices at the National German Paul-Ehrlich-Institute.
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.