The risk management process presented in ISO 14971 includes:
1) Identifying hazards and hazardous conditions associated with a medical device that could place patients or healthcare workers at risk.
2) Estimating the potential occurrence of such risks, and evaluating the extent of the consequences.
3) Developing and implementing active safeguards within the device or the production process to control risks.
4) Regularly reviewing and monitoring the process to assess the effectiveness of risk management controls and the risk management process.
Each aspect of a risk management system is thoroughly documented to provide evidence of the manufacturer’s commitment to control risk throughout the entire life of a given medical device design.
A robust risk management system can also provide important value by supporting the development, production and distribution of all types of new medical devices. Products under development are subject to greater scrutiny early in the design stage. This allows for the identification and implementation of changes and modifications to improve functional safety and usability with minimal impact to the product development schedule. For certain types of medical devices, an effective risk management evaluation will also identify risks associated with device reprocessing and reuse. These and other benefits can result in faster time to market, and greater competitive advantages.
TÜV SÜD’s industry specialists and clinical practitioners are experts in the review and assessment of risk management systems and supporting technical documentation, and have extensive experience in the auditing of risk management systems. In addition, TÜV SÜD Product Service is recognised by regulatory authorities throughout the world for its technical and regulatory expertise in medical devices, and is familiar with the regulatory requirements for medical devices in major medical device markets.
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