Risk management is of such vital importance in the development of medical devices that a separate standard was devised to ensure the adequacy of hazard reduction processes. ISO 14971, a standard titled Medical devices — Application of risk management to medical devices aims to ensure that medical end products (devices) are as free of hazards as reasonably possible. It specifies a process for identifying, analyzing, and controlling (reducing or mitigating) all risks, and to monitor the effectiveness of your risk management lifecycle. Watch this webinar recording to learn more about the practicalities of managing risks in complex medical (embedded) software projects. This webinar recording covers the planning and execution of a comprehensive risk management lifecycle, from analysis through reduction to reporting and compliance.
22 June 2016