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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