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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 Health Innovation Leader & Venture PartnerFour Points Health
Aahuti Rai
Health Innovation Leader & Venture PartnerFour Points Health
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

About Us

HLTH Inc. is a dynamic community delivering unique value to the healthcare industry through a mix of unparalleled global events, inspirational content, and impact-driven initiatives.

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USA Event Dates

2026 | HLTH: Nov 15 – 18 | Las Vegas | Register | Sponsor
2027 | ViVE: Mar 14 – 17 | Nashville | Be First to Know | Sponsor
2027 | HLTH: Oct 17 - 20 | Las Vegas, NV

Europe Event Dates

2027 | HLTH Europe: June 21 - 24 | Amsterdam
2028 | HLTH Europe: June 19 - 22 | Amsterdam

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