- Both the EU Medical Device Regulation (MDR - (EU)2017/745) and the In-Vitro Diagnostic Regulation (IVDR - (EU)2017/746) were formally published on May 5, 2017, and they took effect on May 25, 2017.
- To follow clear regulatory pathway for approval of Medical Device
- To perform In-Vitro Device Regulation as a Consultancy Services
- Transition services from MDD to MDR, maintaining compliance
- MDR 2017/745
- Transition services from IVDD to IVDR
- Gap Analysis for new regulation
- New MDR and IVDR consultation services
- Technical Documentation
- Labelling reviews and updates
- Unique Device Identification or UDI creation service
- Post-Market Surveillance (PMS).
- Technical documentation gap analysis in accordance with MDR/IVDR requirements
- Writing and updating Performance Evaluation Plans and Reports in accordance with IVDR regulations
- The quickest and simplest option to introduce the device into numerous markets with a single audit is through registration through MDSAP.
Medical Device Management
Medical Device Management
