rISK Management

Medical Device Risk Management and Assessment

 

Risk management is a fundamental element of medical device design, production and distribution. Medical device manufacturers are required to use a risk management assessment process to reduce and/or eliminate risks associated with their products. Risk management requires all potential medical device risks to be identified, evaluated and alleviated to the fullest extent possible.

 

A risk management system is obligatory for all types of medical devices. The FDA uses ISO 14971 as a reference for risk management procedures. ISO 14971 establishes requirements for manufacturers to perform risk management to certify that every medical device is safe for its intended use.

 

The team of expert consultants at REU Associates can aid with risk management training and risk assessment, as well as the development, implementation and management of your risk assessment process. We will help your organization establish the best practices and procedures to systematically analyze, evaluate, control, and monitor medical device risks and ensure compliance with ISO 14971 and international regulatory requirements. Contact us today for more information about our risk management consulting solutions.

Email: support@reuassociates.com