Risk Management in Medical Devices Industry

Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment. Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations.By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.

Topics: medical device risk management training, ISO 14971 workshop, ISO 13485, quality system integration, IEC62304, IEC62366-1/-2, risk management life cycle, FDA software reviewers' guidance, SOP framework, risk rating methods, european special requirements, risk management report