ISO 14971 is the international standard for the application of risk management to medical devices. This tutorial is intended to introduce the attendees to the core concepts for medical device risk management and familiarise them with the requirements of ISO 14971.
This tutorial is aimed at people who have no prior experience with risk management of medical devices. It is suitable for people who will be performing risk management, and also for people who need a general understanding of risk management (e.g., Regulatory, R&D, or management.), but will not perform risk management activities themselves.