ABSTRACT

Medical devices play a vital role in modern healthcare, facilitating diagnosis, treatment, and patient care. As the complexity and diversity of medical devices grows it is essential to ensure the safety of the medical devices. This article presents a comprehensive review of the different testing methods followed for the safety assessment and process which needs to be followed to achieve a more effective and systematic approach to evaluating medical device safety. The review encompasses of existing safety assessment techniques include pre-market testing, risk management, quality management system, post marketing surveillance. The potential benefits of the proposed framework are significant, as it promises to enhance the overall safety and reliability of medical devices, reducing the occurrence of adverse events and improving patient outcomes.by enabling a more comprehensive and data-driven approach to safety assessment, healthcare systems can gain valuable insights into device performance, facilitate informed decision making, and foster innovation in the medical device industry. Keywords: Medical Devices, Safety Assessment, Risk management, Post marketing Surveillance
Publication date: 01/08/2024

https://ijbpas.com/pdf/2024/August/MS_IJBPAS_2024_8258.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.8.8258