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

 

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