Post Market Surveillance and Vigilance
Post-market surveillance (PMS) is a critical component in ensuring the continued safety and performance of medical devices and in vitro diagnostic devices once they are placed on the market. This process is fundamental for identifying and managing any issues that may arise during real-world use, thus ensuring long-term compliance with European regulations, namely MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746).
We provide expert consultancy for the implementation of post-market surveillance and post-market clinical follow-up (PMS/PMCF) systems, helping ensure that your devices remain compliant and safe for end users.
Our services include
Development and implementation
Development and implementation of PMS/PMCF systems to continuously monitor device safety and performance
Management and analysis of incidents
Management and analysis of incidents and adverse events, based on data collected during device use
Support in identifying, assessing, and managing risks
Support in identifying, assessing, and managing risks, ensuring timely and effective responses to potential issues
Management of recalls and withdrawals
Management of recalls and withdrawals, including coordination of communication with competent authorities and customers
Periodic surveillance reports
Preparation and submission of periodic surveillance reports
Consulting
Consultancy in the development of risk mitigation plans and updates to strategies based on surveillance outcomes
