Abstract
Postmarketing surveillance (PMS) is a critical process for ensuring the safety and efficacy of medical devices once they have been approved for use. The purpose of PMS is to monitor the performance of medical devices in real-world environments and identify any adverse events or safety issues that may occur. This paper provides an overview of the PMS process for medical devices, highlighting key challenges and opportunities for improvement. It also discusses regulatory requirements for PMS, including the need for robust reporting systems and the importance of timely and accurate data collection. The role of stakeholders, such as healthcare professionals and patients, in reporting adverse events and providing feedback on device performance is also described. Overall, this paper highlights the critical importance of PMS in ensuring the safety and efficacy of medical devices and emphasizes the need for continuous evaluation and improvement of PMS programs to meet the evolving needs of patients and healthcare systems.
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Judd, T. (2024). Post-market Surveillance (PMS) of Medical Devices: From a Clinical Engineering Perspective. In: Badnjević, A., Cifrek, M., Magjarević, R., Džemić, Z. (eds) Inspection of Medical Devices . Series in Biomedical Engineering. Springer, Cham. https://doi.org/10.1007/978-3-031-43444-0_5
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