Medical Device Software Regulation and Compliance 2021

This training day was already arranged in co-operation with USBIMED and QAdvis AB in May 2018 and June 2019. As a response to requests, this succesfull training day will be arranged again since a lot is happening at the moment in relation to regulations and software in EU and also globally.

Thie content of this training is updated and represents both current know-how and the future perspective.

Time: Wednesday, 24 March 2021, 9:00-16:30
Place: Online, webinar (Teams -link will be sent one week before the event)
Practical organizer and host: USBIMED (Terhi Holappa)
Instructor: QAdvis AB, Stockholm, Sweden (Robert Ginsberg, Mikael Dahlke, Cecilia Emanuelsson)
This webinar will be held in English.

Registration by 24 February 2021.

Target group

Prioritized especially for 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.

Aim of the training day

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).

Visit the webinar website for more information.

Contact person

Terhi Holappa
+358 40 5595 726