Post-market surveillance (PMS) is the continuous monitoring of a device’s performance and safety once it’s on the market. It’s a legal requirement under MDR Annex III, designed to ensure manufacturers remain responsible for their products throughout the entire lifecycle.
Effective PMS isn’t just about reacting to complaints; it’s about proactively identifying trends, risks and opportunities for improvement. A well-structured PMS system can reduce recalls, inform product development and demonstrate regulatory maturity.
Clinera Solutions develops PMS reports (including Periodic Safety Update Reports) that transforms compliance into a strategic advantage. We integrate data from vigilance reports, literature, complaints and user feedback to provide meaningful insights for continuous improvement.
All our PMS documentation is developed in line with MDCG 2017-1, MDCG 2020-6 and MDR Annex III.
Our post market surveillance services include:
Other Services
Why choose us?
At Clinera Solutions, expertise is built into every document delivered. Each project benefits from years of hands-on experience in clinical and regulatory writing, with a focus on accuracy, efficiency, and clear clinical storytelling.