Medical Device Regulation (EU) 2017/745 (MDR)

I support Legal Manufacturers, Importers and Distributors to ensure compliance with Medical Device Regulation (MDR).

The tasks are typically:

• Introduction and overview of requirements in Medical Device Regulation (MDR)
• Detailed analysis of requirements for the specific company and/or products
• Gap analysis between existing set-up and MDR including proposal for implementation
• Classification of products
• Implementation of UDI and Basic UDI
• Readiness for reporting to EUDAMED
• Implementation / optimization of quality management system in compliance with ISO 13485
• Implementation / optimization of  quality management system for importers and distributors