Efficient medical device quality management and testing
ISO 14971, Medical devices - Application of risk management to medical devices, details the risk management principles and practices as referenced in a number of key medical device standards, including the 3rd edition of IEC 60601-1 (electrical safety), ISO 13485 (quality management systems), IEC/EN 62366 (Usability of medical devices), ISO 10993 (biological evaluation) and IEC 62304 (medical device software). As such, compliance with the provisions of ISO 14971 is essential for manufacturers of medical devices seeking regulatory approval in the U.S., the European Union (EU), Japan, Australia and other major international markets.
The risk management process presented in ISO 14971 includes:
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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