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Certifications for medical device manufacturers – what is changing?

  1. Certification
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  3. Medical Device Manufacturers

The importance of technology in medical diagnostics and treatment is growing from day to day. As a result, the legal requirements for manufacturers and operators of medical devices are constantly changing.

With our internationally recognized testing and certification programme, we provide maximum assurance of safe use of medical devices and equipment in hospitals, clinics, medical practices and medical and rehabilitation facilities.

Our services include tests and certifications related to CE marking, and we also hold national and international accreditations for the certification of QM systems in accordance with ISO 13485. In addition, we are approved for certification of active and inactive medical devices and also active implantable medical devices by the Central office of the countries for health protection for medicinal products and medical devices (ZLG, Competent Authority). (Notified Body, Identification Number 0044)

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

Services:

TÜV NORD Hersteller Dienstleister Händler Medizinprodukte
MDSAP
MDSAP - Certification standard for five markets
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MDR
MDR (Medical Device Regulation) - the new medical device regulation
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TÜV NORD DIN EN 15224 Gesundheitswesen
ISO 13485
ISO 13485 - the process-oriented standard for medical device manufacturers
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