MDR Compliance

In 2017, the new European Medical Device Regulation (MDR) and the Regulation on In-Vitro Diagnostic Medical Devices (IVDR) came into force. These replace the existing directions on medical products.

EXCO supports a client by ensuring compliance with the requirements of the new EU MDR/IVDR. This includes indivdual consultation with recommendations for action and the specific implementation of entire work packages.


Implementation

EXCO was commissioned to support the client by:

  • consulting in all relevant MDR topics
  • assessment of existing documentation
  • gap analysis (93/42/EEC -> EU 2017/745) 
  • planning measures to close gap
  • revision of existing processes

 


Customer benefit
  • Efficient support of client's core compliance team
  • Short-term availability of MDR specialists
  • Remote and on-site deployment of the MDR specialists
  • One contact for all sub-projects

Client

Manufacturer of active medical devices, Germany

Your expert contact - Projects Switzerland

Jörg Petrullat

T+41 41 455 24 76