Download our complete MDR package with checklists/ gap assessments, guidance documents and templates to the new EU MDR. The templates and guidance have been carefully put together following the relevant Articles and Annexes of the regulations. Get ahead of your competition and be compliant ready before others!
- CE Technical File for MDR
- Post Market Clinical Follow Up Plan and Report
- PMS Gap Assessment
- Periodic Survey Update Report
- Guidance for Unique Device Identifier (UDI)
- Economic Operators Gap Assessment
- Guidance for EU MDR Software as a Medical Device (SaMD)
- EU MDR Procedure Packs
We also We offer an extensive range of training courses designed by a carefully selected panel of Medical Devices experts bringing together years of experience and knowledge. Click HERE to find out more!