In addition to QM system certifications in accordance with EN ISO 13485:2012 and DIN EN ISO 9001:2008, we also offer certifications in accordance with the EU Directives regarding medical devices and active implantable medical devices. The proven fulfilment of the applicable EU directives is the legal prerequisite for introducing such devices to the European domestic market.
We are notified by Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) for active and non-active medical devices as well as active implantable medical devices (Notified Body, Ident. No. 0044).
We are also accredited by the German Accreditation Body DAkkS as a certifier of management systems for medical devices according to DIN EN ISO 13485.
We certify in accordance with the following standards and directives:
The CE marking is used to express compliance of the devices with these directives. The conformity declaration associated with this requires, depending on the type and classification of the devices, specific safety aspects to be tested and the use of different conformity assessment procedures. Detailed information on the various conformity assessment procedures can be found in our information folder regarding CE marking.
Based on a completed client questionnaire we will be pleased to make you an offer for certification of management systems and certification of products and quality management systems for medical devices.
Further TÜV NORD CERT is notified by the ZLG for conformity assessment in accordance with Annex III and Annex IV of the EC-Directives for medical devices. We also conduct product design examinations in accordance with Annex II.4 of the EC medical devices directives (design dossier).