Post-Market Surveillance and Vigilance | MDV-Solve
Post-Market Surveillance & Vigilance
A proactive PMS system is mandatory under MDR. We help you set up systems to monitor device performance and manage vigilance reporting.
PMS & Vigilance support:
- PMS Plan and Report / PSUR
- Vigilance reporting (MIR form)
- Trend analysis and signal detection
- Field Safety Corrective Actions (FSCA)
- PMS procedure development
Related Services
Design Control Under EN ISO 13485 & 21 CFR PART 820
Establish and implement a system for design controls for various classes of medical devices.
+ Learn MoreThe New EU IVD Regulation (IVDR)
The In Vitro Diagnostic Regulation stipulates all requirements IVD manufacturers must comply with.
+ Learn MoreGood Manufacturing Practice (cGMP)
Establish and implement an effective tailored cGMP system in line with requirements.
+ Learn More