Medical Devices: Classification, Regulatory Framework, and Risk Management Approaches – A Comprehensive Review

Abstract

Medical devices play an important role in healthcare systems today. Devices are used for diagnostic, monitoring, preventive, and therapeutic purposes. Progress in the field of biomedical engineering, artificial intelligence, software systems, and digital health solutions has made a positive impact on patient outcomes and healthcare delivery. On the other hand, the increasing complexity of devices has been accompanied by safety issues, regulatory concerns, cybersecurity threats, and risk factors that need to be addressed. This review provides a broad analysis of different aspects associated with medical devices, including classification schemes, regulation frameworks, development processes, quality management systems, human factors engineering, clinical evaluation, and post-market surveillance programs. In addition, the paper discusses the concept of global harmonization, risk management tools, safety standards established by the International Electrotechnical Commission, and modern technologies used in medical devices such as Software as a Medical Device (SaMD), wearables, and artificial intelligence-based solutions.