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27 Sep 2022 | 02:45 PM GMT
Past Meeting

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 Health Innovation Leader & Venture PartnerFour Points HealthHealth Tech & Solutions
Health Tech & Solutions
Aahuti Rai
Health Innovation Leader & Venture PartnerFour Points Health
Barry Curran Principal Software & Product SecurityMedtronicOther
Other
Barry Curran
Principal Software & Product SecurityMedtronic
Dr. Nick (Nemanja) Kovacev Head of Healthcare and Life Sciences PracticeHTEC GroupHealth Tech & Solutions
Health Tech & Solutions
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.Health Tech & Solutions
Health Tech & Solutions
Ferry Tamtoro
Co-founderBrightInsight, Inc.
Gregoire Guillet CBO - Digital FactoryServierLife Sciences, Pharma & Biotech
Life Sciences, Pharma & Biotech
Gregoire Guillet
CBO - Digital FactoryServier
Maria Ilia Associate Director RWE, ConsultancyOPEN HealthOther
Other
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

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, TN | Be First to Know | Sponsor
2027 | HLTH: Oct 17 – 20 | Las Vegas, NV

Europe Event Dates

2027 | HLTH Europe: Jun 21 – 24 | Amsterdam | Sponsor
2028 | HLTH Europe: Jun 19 – 22 | Amsterdam

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