This training day was first arranged in co-operation with USBIMED and QAdvis AB in May 2018. As a response to requests and because of the fact that a lot is happening in terms of regulations and software bot in the EU and globally, the training will be organised again. Its content has been updated and represents current know-how with future perspective.
Time: 6 June 2019, 8:30-16:30
Place: Tapahtumatalo Bank, Helsinki
Practical organizer: USBIMED
Minimum number of booked places needed: 20
Maximum number of places: 30
Aim of the training day
- To update the status of the regulatory requirements of medical SW according to MDR 2017/745.
- To learn about best ways how to utilize IEC 62304 and IEC 82304-1 in practice for compliance (EU).
- To deepen the understanding of medical software risk management.
The training covers software incorporated in device (medical device SW) and software that are devices in themselves (SW as medical device). During the training, day current topics will be discussed, such as artificial intelligence and cybersecurity.
The instructor: Robert Ginsberg, QAdvis AB
Robert has 30+ years of experience of software development, and the entire chain for product development, Agile, Lean and quality assurance in Medtech environments. He has implemented modern software techniques and methods in several companies.
Target groups
This training is prioritized especially for medical device product companies and also for research projects and actors of healthcare units working with medical software and digital health products. This training day is also suitable for all software or regulatory affairs professionals who work with the theme in practice or who are leading these activities.
Read more information and register by 7.5.2019.
Contact person
Terhi Holappa
Entrepreneur (CEO), USBIMED
terhi.holappa@usbimed.fi
+358 40 5595 726