Aim of the training day
To update you on the status of the regulatory requirements on medical device software according to MDR 2017/745 and IVDR 2017/746. To convey the best ways how to utilize the core medical device software-related standards IEC 62304 and IEC 82304-1 in practice for compliance in the EU. To improve the understanding of medical device software risk management (including an update on the latest cybersecurity standards) and clinical evaluation of medical device software. The training covers software as part of a medical device and software that are devices in themselves (SW as a medical device).
Medicon Village member companies receives a 10% discount