ISO 14971 is an international standard for risk management for medical devices. It has been widely 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.

Following risk management activities we can support you:

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