Implementation of MDR requirements in the Quality System
The Regulation 2017/745 defines the aspects to be included in a Quality Management System and introduces new requirements to be implemented in its QMS.
Merc Team will provide you a qualified support to adapt the organization’s Quality System to the requirements of the new Regulation by carrying out the following activities:
- Prepare a plan for the implementation of the MDR 2017/745 requirements specific to your quality system and based on the classification of medical devices
- Gap analysis of the existing quality system to identify any deficiency with respect to MDR 2017/745
- Implement new requirements in existing procedures and/ or set up new procedures/documentation required by the Regulation