TÜV NORD CERT GmbH
Technology plays an ever more important role in medical diagnosis and treatment. This also means that the legal framework for manufacturers and sellers of medical devices is subject to continual change.
With our internationally recognised testing and certification programme we offer hospitals, clinics, medical practices, rehabilitation centres and medical device stores maximum assurance of safe operation of medical devices and appliances.
Our services include testing and certification for CE marking, MDSAP (medical device single audit programme) and QM systems to ISO 13485. We also offer certification for active and non-active medical devices and active implantable devices. Nofication and accreditation
- Notified Body (CE 0044) for medical devices
- Accredited certification body for DIN EN ISO 13485
- Approval as notified body for the new medical device regulation (EU) 2017/745 is expected shortly (4th quarter of 2021)
TÜV NORD CERT – Your notified partner and certification body for certification and testing of medical devices, quality management and assurance, and so much more.