Post Market Surveillance

A roadmap for Post market surveillance and Post market clinical follow-up plan updates In the medical device industry maintaining high standards of product safety, efficiency and compliance is not only a legal obligation but a commitment to patient safety and innovation. European Union Medical Device Regulation (EU MDR 2017/745) and ISO13485 emphasizes the importance of post-market surveillance (PMS), Post-market clinical follow-up (PMCF) and corrective and preventive action (CAPA) in ensuring safety and effectiveness of the device once they are marketed. CAPA is a cornerstone in achieving this goal by addressing identified issues and mitigating potential risks. When integrated into PMS and PMCF systems, CAPA [...]