Post-Market Surveillance (PMS) & UKRP
Vigilance doesn't stop at launch. Protect your patient safety and your license.
The Challenge
Common pain points that prevent medical device manufacturers from achieving sustainable compliance.
Reactive Data Management
Is your PMS data just sitting in a spreadsheet, analyzed only once a year?
EU MDR Compliance
Are you struggling to meet the strict proactive surveillance requirements of EU MDR?
UK Market Access
Need a UK Responsible Person (UKRP) to keep selling in Britain?
The VigilaMed Solution
Proactive Post-Market Surveillance
We turn reactive complaint gathering into Proactive Post-Market Surveillance, ensuring you detect trends early and satisfy regulators like the MHRA and FDA.
Manufacturing-First Methodology: Our PMS systems provide continuous monitoring, trend analysis, and early warning signals. We also act as your UKRP, ensuring seamless UK market access.
What You Get
Tangible deliverables that deliver immediate value and long-term compliance.
- PMS Plan & Report
- PMCF Strategy
- UKRP Representation Agreement
- Trend Analysis Dashboard
- Regulatory Reporting Templates