Medical services by DEKRA

DEKRA Medical services

Your Notified Body for certification worldwide

Manufacturers of medical devices and In-Vitro Diagnostics (IVD) devices require certificates in order to sell their products in markets around the world. You can call on DEKRA for product certification and certification of your quality management system according to ISO 13485.

When you choose DEKRA, you’re choosing more than just a certifier with an outstanding international reputation. We operate virtually everywhere in the world and our project managers have a background in the medical device or IVD industry, mostly in R&D and/or manufacturing. We participate in all the MRAs and are officially recognized by the FDA and Health Canada. For an overview of our recognitions and scope, click here.

We’re a reliable, flexible, responsible partner. And we understand your need to keep your time to market is as short as possible. There are a number of other good reasons for choosing DEKRA:

  • You’re allocated your own Project Manager
  • We’re a full service provider (combining CE certification with ISO 13485 audits, thus saving you considerable time and money)
  • Faster
  • Modular reviews, pre-approval of clinical protocols and regulatory pathways
  • We offer a fixed programme for Transfer of Certification.

We’re experts in complex regulatory and technical projects and proud to be one of the five largest Notified Bodies in the world. The quality, knowledge, and service of DEKRA are a benchmark in the medical industry.

 

Active Implantable Medical Device Directive (90/385/EEC)You manufacture active medical devices intended to remain permanently in the body. These active implantables are only allowed on the European market if they comply with the Active Implantable Medical Device Directive (90/385/EEC).
 Medical Devices Directive 93/42/EECCompliance with the requirements of Directive 93/42/EEC is mandatory for the sale of medical devices in the EU.
 IVDD (In Vitro Diagnostic Medical Devices Directive 98/79/EC)The EU Directive 98/79/EC applies to medical devices employed for the in-vitro examination of human blood and tissue samples, but which do not come into direct contact with the body.
 Tissues of Animal Origin Directive (2003/32/EC)You manufacture medical devices using tissues of animal origin. This tissue is only allowed on the European market if it complies with the Tissues of Animal Origin Directive (2003/32/EEC) in combination with the Medical Device Directive.
 CMDCAS programmeDEKRA is a recognized registrar for the Canadian Medical Devices Conformity Assessment System (CMDCAS).
 EMC testing & certification

DEKRA has been officially designated to implement the complete conformity assessment of the EMC Directive for access to the EU Medical market.

 Transfer of certification

 

DEKRA assumes the certification of your product from your present Notified Body with the special Transfer of Certification Program.

  IEC 60601 DEKRA has been officially designated to completely implement the conformity assessment of the IEC 60601 for access to the EU market.
 ISO 13485
 

DEKRA has transformed the ISO 13485 certification process into an opportunity for you to improve your company’s efficiency and increase profits.

 ISO 9001

More confidence, improved processes, and lower costs with a DEKRA ISO 9001 certificate.

 Transfer of certification
 

DEKRA assumes the certification of your product from your present Notified Body with the special Transfer of Certification Program.