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Participants:

Brian Flatley VP Consulting Services & US Pharma SolutionsS3 Connected Health
Brian Flatley
VP Consulting Services & US Pharma SolutionsS3 Connected Health
Padraig Maguire Head of Quality & Regulatory AffairsS3 Connected Health
Padraig Maguire
Head of Quality & Regulatory AffairsS3 Connected Health
Aahuti Rai NED, Advisor & Venture PartnerFour Points Health | Conduit Connect
Aahuti Rai
NED, Advisor & Venture PartnerFour Points Health | Conduit Connect
Arnaud Muller CX Excellence & Planning LeaderDaiichi Sankyo
Arnaud Muller
CX Excellence & Planning LeaderDaiichi Sankyo
Brian Mahony Medical Research FellowBioinnovate
Brian Mahony
Medical Research FellowBioinnovate
Maxime Champain Search & Evaluation lead, External InnovationBiogen
Maxime Champain
Search & Evaluation lead, External InnovationBiogen
Sonali Agarwal Senior Manager, Digital Health & InnovationGlaxoSmithKline
Sonali Agarwal
Senior Manager, Digital Health & InnovationGlaxoSmithKline
Thyago Ohana Digital Strategy & Capabilities LeadUCB Pharma
Thyago Ohana
Digital Strategy & Capabilities LeadUCB Pharma

About this Meeting

Are you trying to get your SaMD product regulated in the European Union (EU)? Keep reading, this masterclass is for you! 

Regulation is an absolute essential for digital health companies who want to be accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your SaMD product through regulatory pathways in the EU? Join us in this Masterclass led by S3 Connected Health to learn more about: 

  • Overview of SaMD regulation in the EU 
  • SaMD qualification & classification under the new Medical Device Regulation (MDR) vs. the previous Medical Device Directive (MDD) 
  • SaMD CE marking & related timelines