EU MDR & CE Marking
Navigate the complexity of the European Medical Device Regulation (MDR 2017/745).
What We Do
The EU MDR has raised the bar for clinical evidence and post-market surveillance. We help you upgrade your technical documentation to meet these rigorous new standards.
- MDR Gap Analysis: Identify exactly what's missing from your MDD files.
- GSPR Compliance: Detailed mapping of General Safety and Performance Requirements.
- Clinical Evaluation (CER): MEDDEV 2.7/1 rev 4 compliant reports and literature reviews.
- Post-Market Surveillance (PMS): Robust PMS plans, PMCF strategies, and PSURs.
Deliverables
MDR Transition Plan
Technical File (TD)
CER & PMS Plans
Notified Body Support