POST MARKET SURVEILLANCE PLANS

At Hands on Research, we understand the importance of post-market surveillance in ensuring the safety and efficacy of medical devices. That's why we offer Post Market Surveillance Plan (PMSP) services that help you meet regulatory requirements, including Article 83 of EU MDR, and proactively collect data to ensure continuous product improvement.

A PMSP is a comprehensive plan that outlines the strategies and activities that a manufacturer will undertake to collect, analyse, and act upon data related to the safety and performance of their medical device once it is on the market. It is a critical document that helps manufacturers ensure they meet regulatory requirements and minimise risks associated with their products.

The plan includes both reactive and proactive data collection activities. Reactive data collection involves the monitoring and analysis of adverse events and other safety-related issues that arise once a device is on the market. Proactive data collection, on the other hand, involves the use of various strategies to proactively gather data on device safety and performance, such as surveys, focus groups, and user feedback.

Our team of experts will work with you to develop a customised PMSP that aligns with your specific device and meets the regulatory requirements of Article 83 of EU MDR. We use a cost-effective approach that takes into account the size of your organisation and the complexity of your product.