„MedTech R&D Focal Points“ – free introductory webinar series, consisting of:

• six 45min lectures + 15min question round
• 1 in every two months through the year 2021 (check schedule)
• Introducing Japanese and Chinese regulatory requirements and essentials
• How does the medical device regulations work between Switzerland and EU
• Human Factors Engineering process in international design integrated with Risk Management
• Design V&V in aligned cross-national regulatory framework
• Cross-cultural and cross-national design - what do you need to consider?

• 24.02.2021
• Designing for MedTech Safety
• How to integrate Human Factors Engineering process with Risk Management
• [ANSI/AAMI/IEC 62366-1:2015/A1:2020/ISO 14971:2019]

• 14.04.2021
• Medical Device Regulations in China [NMPA]
• Essentials from device classification to regulatory pathways

• 16.06.2021
• Design Verification & Validation in MedTech
• Design tactics and when do you need them
• [ISO 13485:2016/FDA 21CFR part 820/ISO 9001:2015]

• 18.08.2021 -> Rescheduled to 25.08.2021
• Medical Device Regulations in Switzerland & EU
• How it works and what do you need to know when bringing a product from EU to Switzerland and vice versa

• 20.10.2021
• Cross-cultural and cross-national medical device design
• How culturally specific differences influence medical device safety in international markets

• 15.12.2021
• Medical Device Regulations in Japan [PMD Act]
• Essentials from device classification to regulatory pathways