for your Medical Device in Europe.
Since the enforcements of the regulations regarding Medical Devices, your Business needs a solid roadmap to access the European market or maintain business continuity.
Scan through the most relevant informations easily with our free guide.
- MDD certificate renewal
- Clean Evaluation Plan and Report (CEP and CER)
- Implementing UDI (Unique Device Identification)
- PRRC (Person Responsible for Regulatory Compliance)
- Post-market Surveillance and Post-market Clinical Follow Up
- Technical File assessment
- Notions about EUDAMED
Want to know more?
Check out our solutions for Regulatory Affairs and Compliance.