Date: Monday, 1 October 2018
Location: The Quality Hotel Globe, Stockholm, Sweden
Topic: Implementing the European MDR with Focus on Clinical and Supply Chain/Economic Operators
Meet Jaap Noordmans, Qserve Senior Consultant & Usability Engineering Expert, in person at the TOPRA Annual Symposium 2018.
The TOPRA Annual Symposium 2018 is being held in partnership with the Swedish Medical Products Agency and will be hosted in Stockholm, Sweden between 1–3 October 2018.
Tickets are now available for the Symposium's four separate tracks:
• Medical Devices & IVDs | 1-2 October
Session 3: Digital health and the new General Data Protection Regulation (GDPR)
15.15-16.45 PM - Industry perspective on GDPR preparations:
There are exciting opportunities for digital health with medical devices, with increasing connectivity and convergence with medicinal products enabled by software not imagined when the medical device directive was published. Systems are increasing in complexity, with artificial intelligence coming into play. Software developers may not be familiar with medical device regulations; there are also fears and risks that need to be addressed regarding safety, security and privacy. This session will consider the challenges of regulating in this fast-moving space, including the impact of the General Data Protection Regulation on the medical device sector and how to successfully navigate the minefield of applicable regulations.
- How does cybersecurity relate to GDPR?
- How to integrate security and safety Risk Management.
Read related blog.
- Jaap Noordmans - Senior Consultant, Qserve Group, The Netherlands.
- Philip Siberg - CEO and Co-founder, Coala Life AB, Stockholm, Sweden
- other speakers to be announced
Visit TOPRA's website for more information.