On behalf of the manufacturers, we carry out the necessary certifications as a notified body in accordance with Regulation (EU) 2017/745 (MDR) as part of the CE conformity assessment of the products. Conformity assessment procedures with the involvement of a notified body are mandatory for all manufacturers of series products, with the exception of Class I products (non-sterile, no measuring function, no reusable surgical instruments). The focus of our activities here is both the inspection of the QM system at the manufacturer’s premises and its subcontractors as well as the inspection of the technical documentation of the products concerned. In addition to auditors with industry experience, we have a large number of experts with many years of experience in industry, clinics, testing laboratories and notified bodies at our disposal. Our certification is recognised by our cooperation partners for product approval in Ukraine.

Certification according to QM standards represents real added value for manufacturers of medical devices of all risk classes, whether in series production or as customised products. They receive an objective assessment of their QM system and the underlying company processes. Accredited certification in accordance with EN ISO 13485 confirms that the QM system is suitable for implementing the legal and normative requirements placed on the medical device manufacturer’s organisation. This also supports compliance with Regulation (EU) 2017/745 (MDR).
ISO 13485 is the normative basis for the Medical Device Single Audit Programme (MDSAP) and recognition in Taiwan as part of the Technical Cooperation Programme (TCP).