Post-Market Surveillance (PMS) & Vigilance Services
Regulatory obligations don’t end at approval. Once your device is on the market, Post-Market Surveillance (PMS) ensures it remains safe, effective, and compliant. At MIP, we help you manage these requirements with confidence—across the EU, UK, and beyond.
How We Support You
- PMS Planning & Reporting – Drafting PMS Plans, PMSRs, and PSURs tailored to your devices.
- Vigilance Activities –Managing adverse event reporting and communications with regulatory authorities.
- Corrective Actions – Guidance on Field Safety Corrective Actions (FSCAs) and Field Safety Notices (FSNs).
- Gap Assessments – Reviewing specifications, labelling, documentation, and risk management to ensure compliance.
- PMCF Support – Assistance with Post-Market Clinical Follow-up, an integral part of MDR/IVDR compliance.
- PMS data collection – Actively collect data for your devices
Why Choose MIP?
Regulatory Expertise
Deep knowledge of MDR, IVDR, MHRA, and UK/EU requirements.
Practical Experience
Years of industry know-how to help you avoid pitfalls and delays efficiently.
End-to-End Support
Ensure that strategies are effectively implemented and objectives
