ISO 13485 Certification-Medical Devices-IVD Industry Certification

Medical devices & IVD

Your Notified Body for worldwide certification

You manufacture medical devices. Your products must be furnished with certificates in order to be allowed on the market in various countries. Moreover, your Quality Management System has to comply with the regulations. Obviously, you’re looking for a Notified Body that ties in perfectly with your needs and expectations.

You can call on DEKRA for both your product certification and the certification of your Quality Management System. This efficiency ensures that valuable time is saved. We are proud to be one of the five largest Notified Bodies in the world. The quality, knowledge, and service of DEKRA are the benchmark in the medical industry.

Our services for the medical devices & IVD industry

System certification
Auditing and certification of quality, occupational health & safety and environmental management systems read more

Medical certification

Certification of medical devices, in-vitro diagnostics and quality management systems read more

Personnel certification & training

Approved personnel certification schemes as well as courses, seminars and workshops read more

Product certification
Our services for the medical devices & IVD industry read more