Post-market surveillance system

We assist in the establishment of data collection mechanisms to efficiently gather post-market data from various sources and ensure that risk management processes are integrated into the PMS system, allowing for the early identification and assessment of potential risks associated with your medical devices.

We help develop comprehensive PMS documentation, including operating procedures, data analysis protocols, and reporting templates, ensuring a systematic and organised approach to post-market data handling.

Our services include conducting a PMS gap analysis to identify areas that require improvement to align with regulatory requirements and industry best practices. Based on the analysis results, we work closely with your team to design a customised PMS system that captures relevant data, monitors device performance, and facilitates timely reporting of adverse events and safety issues.