Risk Management Requirements

ISO 14971 is an international standard for risk management for medical devices. It is accepted as a risk management method by, among others, the U.S. Food and Drug Administration, the European authorities, Health Canada and the Australian Health Authority.
As a standardization member of IEC TC62A, ISO TC210 and JWG1, we can provide you with inside information on the changes of the new ISO 14971:2019 and help you gain a competitive advantage.

Need help with the risk management implementation and execution?

We can also provide you with first-hand information of the new ISO 14971/DIN EN ISO 14971:2019. Take advantage of our expertise and be supported in the analysis, preparation and updating of your risk management file, in compliance with the current regulations. Visit our seminar and you will be trained and advised by our experts. Secure valuable competitive advantages and accelerated market access.

Risk Management Services we can support you with:

  • Implementation of a product-specific risk management process according to ISO 14971:2019
  • Risk analysis, assessment and control of medical devices already on the market and for your initial market approval
  • Optimization of implemented risk management processes
  • Integration of the risk-based approach into the quality management system
  • Moderation of risk management meetings

For further details on risk management for medical devices according to ISO 14971 or for a non-binding offer, please contact us. Take advantage of the opportunity to attend one of our seminars.