Post-market surveillance 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 documentation 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 PMS documentation is developed in line with MDCG 2017-1, MDCG 2020-6, and MDR/IVDR 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.