MDR online conference on «SaMD»
Online webinar on the focus topic «Software as Medical Device» from 09.30 – 12.00 h and 13.00 – 15.30 h. The regulatory requirements around «SaMD» will be highlighted – from development to approval to data protection.
The participation fee for members of Swiss Medtech, SVDI, ASDI, companies from the canton of Solothurn as well as start-ups (year of foundation in the last three years) is CHF 140. Non-members can register for a fee of CHF 230.
MDR online conference
25 March 2021
Webinar
09.30 – 12.00 h
13.00 – 15.30 h
«Software as Medical Device»
Programm
Session 1 (09.30 – 10.20):
SaMD: an overview, including applicable standards
Speaker: Hansjörg Riedwyl (ISS AG)
Session 2 (10.20 – 11.10):
Agile software development in a highly regulated environment
Speaker: Lukas Ackermann (Galenica)
Session 3 (11.10 – 12.00):
Cybersecurity aspects in the development of a medical device
Speaker: Mathias Eng (PROREGIA AG & QUAREGIA GmbH), Dr. Larissa Naber (PROREGIA AG) and Matthias Steck (ISS AG)
Session 4 (13.00 – 13.50):
Qualification, classification and regulatory approval of SaMD under MDR (including clinical aspects)
Speaker: Jana Moravcova (MTE) and Rok Hrovatin (Cosylab)
Session 5 (13.50 – 14.40):
Legal aspects with regard to data protection (including GDPR)
Speaker: Francesca Blythe (Sidley Austin LLP) and Josefine Sommer (Sidley Austin LLP)
Session 6 (14.40 – 15.30):
Medical Devices with Artificial Intelligence, current status
Speaker: Yannick Soom (ISS AG) and Salvatore Scalzo (European Commission)
15.30 h: End
Recording
Provided on request.
