Advances in the Standards & Applied Sciences

Advances in the Standards & Applied Sciences

The Importance of Risk Management for Medical Devices

Document Type : Letter to Editor

Authors
Marzieh Reza 1
Ali Tavakoli Golpaygani 2
1 Iran, Tehran, Shahriyar, Baghestan, Valiasr Blv, Reyhan St, No 46,Floor 1
2 Biomedical Engineering Research Group, Research Center of Technology and Engineering, Standard Research Institute, Karaj, Iran
10.22034/asas.2024.413019.1035
Abstract
Medical devices play a pivotal role in modern healthcare, contributing to improved patient outcomes and enhanced quality of life. However, with their growing complexity and integration into various medical practices, there is a pressing need to address potential risks associated with their use. This implies that the device should be safe and effective and risk analysis plays a key role in the development of medical devices design. The goal is to minimize related use hazards and, assure the final users are able to use medical devices safely and effectively throughout the product life cycle.
This note highlights the significance of risk management in the medical device industry and explores how effective risk management strategies can ensure the safety and efficacy of medical devices, ultimately benefiting both patients and healthcare provider.
Keywords
Risk Management
Medical Devices
ISO 14971
Subjects
1. AAMI TIR 57:2016, Principles for medical device security — Risk management.
2. ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes.
3. ISO – ISO 14971:2019 – Medical devices — Application of risk management to medical devices.
4. ISO – ISO/TR 24971:2020 – Medical devices — Guidance on the application of ISO 14971.
5. Elahi, B., 2021. Safety risk management for medical devices. Academic Press.
6. Carden, L. and Oladapo, B., 2021. An ethical risk management approach for medical devices. Risk management and healthcare policy, pp.2311-2318.
7. Bartoo, G., 2003. Risk management [medical devices]. IEEE Engineering in medicine and biology magazine, 22(4), pp.166-172.
8. Singh, K. and Selvam, P., 2020. Medical device risk management. Trends in Development of Medical Devices, pp.65-76.
9. Dumbrique, R., 2011. Implementation of risk management in the medical device industry. San Jose State University.
10. Jones, P.L. and Taylor, A.L., 2015. Medical device risk management and safety cases. Biomedical Instrumentation & Technology, 49(s1), pp.45-53.
Advances in the Standards & Applied Sciences
Volume 2, Issue 2
Winter 2024
Pages 1-3