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27 Sep 2022 | 02:45 PM GMT

Masterclass: Translating European Regulatory Guides into Practical Steps for DTx Solutions

Anchored by:

Adriano Garcez
Director, DTx/SaMD Evidence Generation
ZS ASSOCIATES

Participants:

Adriano Garcez Director, DTx/SaMD Evidence GenerationZS Associates
Adriano Garcez
Director, DTx/SaMD Evidence GenerationZS Associates
Meaghan Schedel Senior Digital Health ConsultantHealthXL
Meaghan Schedel
Senior Digital Health ConsultantHealthXL
Aahuti Rai NED, Advisor & Venture PartnerFour Points Health | Conduit Connect
Aahuti Rai
NED, Advisor & Venture PartnerFour Points Health | Conduit Connect
Barry Curran Principal Software & Product SecurityMedtronic
Barry Curran
Principal Software & Product SecurityMedtronic
Dr. Nick (Nemanja) Kovacev Head of Healthcare and Life Sciences PracticeHTEC Group
Dr. Nick (Nemanja) Kovacev
Head of Healthcare and Life Sciences PracticeHTEC Group
Elaina Bolinger Senior Insights ManagerBayer AG
Elaina Bolinger
Senior Insights ManagerBayer AG
Emma Carr Co-Founder and Chief Scientific OfficerAmara Therapeutics
Emma Carr
Co-Founder and Chief Scientific OfficerAmara Therapeutics
Ferry Tamtoro Co-founderBrightInsight, Inc.
Ferry Tamtoro
Co-founderBrightInsight, Inc.
Gregoire Guillet Chief Business and Value OfficerWeHealth Digital Medicine
Gregoire Guillet
Chief Business and Value OfficerWeHealth Digital Medicine
Maria Ilia Associate Director RWE, ConsultancyOPEN Health
Maria Ilia
Associate Director RWE, ConsultancyOPEN Health
Stephen Gibney Snr Director - DPI SaaS Quality LeadPhilips
Stephen Gibney
Snr Director - DPI SaaS Quality LeadPhilips

About this Meeting

Are you trying to commercialize a digital therapeutics (DTx) solution in the European Union (EU)? Would you like to learn practical steps on how to navigate the European regulatory landscape? Keep reading, this masterclass is for you! 

Regulation is an absolute essential for companies who want to commercialize regulated medical devices. The new Medical Device Regulation (MDR) in Europe can be complex and confusing, and most companies struggle to navigate it efficiently. What are the do’s and don’ts when attempting to take a DTx product through regulatory pathways in the EU? Join us in this masterclass led by BlueBridge Technologies to learn more about:  

  • Overview on SaMD qualification & classification under the new Medical Device Regulation (MDR): what does it mean in practice? 
  •  DTx solutions change very quickly to ensure high quality treatment and security standards. But submitting every change to regulators is not efficient for anyone. What are regulators requirements to DTx product changes? How can we deal with that? 
  •  What is coming into the EU: guidelines and requirements for the use of Artificial Intelligence in Medical Device