Gap Analysis for EU MDR 2017/745

Gap Analysis

Are you looking for assistance with Gap Analysis?

Manufacturers all over the world need to transition to the MDR in the coming years. Qserve's specialized team could help you identify the best strategy for your company. 

The transition to the MDR is a lot of work because compared to the MDD, the MDR introduces a life-cycle approach for the CE Marking Compliance. The conformity assessment procedures are more complex, and your clinical data will need recurring updates.

The GAP analysis will be performed by cross-functional teams, depending on the size of your organization. The GAP analysis will generate a task list for updating your procedures and documentation. Our Qserve consultants can support with this.

What will be reviewed in an EU-MDR Gap Analysis:

• Product class and families
• Technical file
• Clinical Evaluation Reports
• Labeling
• Post Market Surveillance
• Supply chain and distribution
• Notified body status
• Economic Operators
• Risk management file