MENU

Certifications for medical device manufacturers – what is changing?

  1. Certification
  2. Branches
  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!

Services:

medizinprodukte-hersteller-dienstleister-haendler
MDSAP
MDSAP - Certification standard for five markets
Read more
MDR
MDR (Medical Device Regulation) - the new medical device regulation
Read more
medizinische-einrichtungen-din-en-15224
ISO 13485
ISO 13485 - the process-oriented standard for medical device manufacturers
Read more

More Information:

Customer Login

Unannounced Audits

We are looking forward to your inquiry

In order to provide you with a pleasant online experience, we use cookies on our website. By expressing your consent at tuev-nord.de you agree to the use of cookies. Further information, e.g. how you can object to the use of cookies at any time, can be found in our data protection and data protection settings.