Why should a company worry about post-market surveillance?
In short, almost 60% of FDA citations between FY22 and FY24 were related to PMS issues, making this an issue that companies cannot afford to take lightly. It is critical for patient safety, to comply with regulatory requirements, and it makes manufacturers accountable.
What is post-market surveillance for medical devices?
Post-market surveillance serves as a vital mechanism for tracking the real-time performance and safety of medical devices once they are in use. Initial tests and clinical trials are incredibly insightful but do not always capture the full spectrum of potential issues in diverse, everyday environments. Post-market surveillance seeks to fill this gap, offering a broader, more fluid perspective by analysing real-world usage data and experiences.
This ongoing monitoring is critical to validating medical devices’ practical safety and utility. It provides a pathway for manufacturers to receive and integrate user feedback, crucial for refining and advancing their products. Beyond enhancing device quality, this surveillance is essential for regulatory compliance, aligning with governing bodies such as the FDA in the United States, the European Commission in the European Union, and Health Authorities globally.
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