What is ISO 14971

Risk analysis alone no longer meets international requirements. ISO 14971:2000, Application of Risk Management to Medical Devices, is now the harmonized standard in Europe and a recognized consensus standard in the US. Manufacturers must manage medical device risks through the entire product life cycle - from concept to market introduction through obsolescence. Further emphasizing the importance of this topic, compliance with ISO 13485:2003 cannot be achieved without a risk management process in place. ISO 14971:2000 is cited as a system that meets this requirement.

Keystone Regulatory Services helps you integrate your risk and quality management systems. We ensure that your Risk Management System dovetails with your QMS.

Our training programs range from executive briefings to two-day detailed courses. We also provide hands-on risk management support for your product development teams. Contact us to discuss your requirements.