Post-Market Surveillance (PMS)

Securing a successful market launch is a monumental achievement, but the reality of the infinite game is that compliance does not stop at launch. While many manufacturers focus their ongoing compliance efforts strictly on European Union obligations, true market leadership demands a much broader perspective. Managing ongoing product safety means navigating complex international incident reporting mechanisms and maintaining stringent global Vigilance requirements. To protect your users and your brand, we design global PMS and Vigilance plans that synchronise EU Periodic Safety Update Reports (PSUR), UK MHRA Yellow Card reporting, and US FDA Medical Device Reporting (eMDR) alongside CPSC SaferProducts data. By harmonising these diverse international channels, we ensure your organisation is fully equipped to mount rapid, integrated responses to real-world field data. We believe that waiting for a regulatory audit or a critical failure is an unacceptable strategy. We strive for excellence by building proactive surveillance systems based entirely on rigorous, evidence-led decisions. As a deeply client-focused organisation, we integrate seamlessly with your existing teams. Together, we optimise your post-market processes to catch issues early, definitively reduce your long-term risk, and continuously improve product safety throughout the entire lifecycle of your innovation.