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.