Medical Device Software Regulation and Compliance 2021
USBIMED in co-operation with QAdvis AB is organizing a training day Medical Device Software Regulation and Compliance 2021 on Wednesday 24.3.2021, 9:00-16:30.
The aim of this training day is to update the status of the regulatory requirements of medical device SW according to MDR 2017/745. To learn the best ways how to utilize core medical device software-related standards IEC 62304 and IEC 82304-1 in practice for compliance (EU). To deepen the understanding of medical device software risk management (including cybersecurity) and clinical evaluation of medical device software. Training covers software as part of medical device and software that are devices in themselves (sw as medical device).
The training day is prioritized especially for Finnish medical device product companies, research projects and healthcare units developing medical software and digital health products or services. This training day is also suitable to all software or regulatory affairs professionals in general who work with theme in practice or are leading these activities.
Registration by 24 February 2021.