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Compliance assessment improves safety and management of medical devices, indicating vital support for health systems.
To ensure effective management of medical devices, it is imperative that medical devices must be safe and inoffensive, and their management must be based on evidence. Thus, to help enhance the safety of medical devices, a new mechanism for the periodic compliance assessment of medical devices has been developed. The mechanism involves the assessment of general safety, electrical safety and performance parameters in line with international best practice. At the same time, the effective management of medical devices requires data and information related to medical devices and their lifecycle events, which can be obtained through the medical device management information system. The establishment and implementation of efficient management of medical devices, involves strengthening the capacities of medical devices’ management, in order to be able to respond to the current requirements of the health system, in such a way as to ensure the functionality of medical devices and the safe and efficient use of medical devices. Accordingly, the implementation of efficient management of medical devices is fundamental for providing qualitative, safe and efficient medical devices, which contributes to increasing the quality of medical services.
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Gheorghe Gorceag (2025) studied this question.
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