Certifications for medical device manufacturers – what is changing?

  1. Certification
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  3. Medical Device Manufacturers

Technology is becoming increasingly important in medical diagnostics and treatment. As a result, the legal requirements for manufacturers and operators of medical devices are constantly changing.

With an internationally recognized testing and certification program, we offer hospitals, clinics, medical practices or medical and rehabilitation facilities maximum safety for the safe operation of medical products and equipment.

Our services include tests and certifications relating to CE marking, national and international accreditations for the certification of QM systems in accordance with ISO 13485, active and inactive medical devices and active implantable medical devices, as well as the certification by the Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) (notified body, identification number 0044).

Medical Device International - Your support on the global market by TÜV NORD!


MDSAP - Certification standard for five markets
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MDR (Medical Device Regulation) - the new medical device regulation
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ISO 13485
ISO 13485 - the process-oriented standard for medical device manufacturers
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