ISO-FDIS 14971:2017 is an international standard that provides guidance on risk management for medical devices. This standard is applicable to all stages of the life cycle of a medical device, from design and development to production, distribution, and use.
Understanding the Scope
The scope of ISO-FDIS 14971:2017 covers all types of medical devices, including active devices, non-active devices, in vitro diagnostic (IVD) medical devices, as well as combination products. It applies to both manufacturers and regulatory bodies involved in the field of medical device development and production.
Key Requirements
This standard emphasizes the importance of identifying and evaluating risks associated with medical devices. It provides a systematic framework for risk management and encourages a proactive approach to minimize potential harm to patients, users, and others affected by the devices.
The key requirements of ISO-FDIS 14971:2017 include:
The establishment of a risk management process, which involves risk analysis, evaluation, control, and reduction;
The consideration of factors such as the intended use of the device, characteristics of the user, and the environment in which the device will be used;
The documentation and maintenance of risk management activities throughout the entire life cycle of the device;
The implementation of post-market surveillance to monitor any potential risks associated with the device after it is released onto the market.
Benefits and Compliance
Compliance with ISO-FDIS 14971:2017 brings several benefits to medical device manufacturers. It helps them meet regulatory requirements, enhance product quality and safety, and gain competitive advantage in the market. By following this standard, manufacturers can improve their risk management processes and ensure that their devices are safe and effective for their intended use.
In addition, compliance with ISO-FDIS 14971:2017 can also enhance communication and collaboration between manufacturers, regulatory bodies, and other stakeholders in the medical device industry. It provides a common language and framework for discussing and addressing potential risks throughout the device life cycle.
Overall, ISO-FDIS 14971:2017 is an essential standard for any company involved in the development and production of medical devices. It sets clear guidelines for risk management and emphasizes the importance of patient safety. Compliance with this standard not only benefits the manufacturers but also ensures the well-being of patients and users of medical devices.
Nina She