In addition to QM system certifications in accordance with EN ISO 13485 and DIN EN ISO 9001, we also offer certifications in accordance with the EU regulation 2017/745 (MDR). The proven fulfilment of the MDR 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 (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.