ISO 14971:2019 Risk Management for Medical Devices

This risk management training webinar provides an overview of changes to the risk management standard (ISO 14971:2019), the associated guidance documents (ISO/TR 24971:2020), and the new European Requirements as outlined in Annex I of Regulation (EU) 2017/745. During this webinar you will learn the difference between a process risk analysis and the risk management activities associated with design of medical devices. You will also learn how to create a risk management plan.