USAEUROPEViVE
ABOUTSPONSORSHIPFOUNDATION
Logo Hlth
Logo Hlth
15 Jun 2021 | 02:30 PM GMT
Past Meeting

Masterclass: The Regulation of DTx

Anchored by:

Stephen Gibney
Snr Director - DPI SaaS Quality Lead
PHILIPS
Hicham Naim
VP, Head of Strategy & Transformation
TAKEDA

Participants:

Hicham Naim VP, Head of Strategy & TransformationTakedaOther
Other
Hicham Naim
VP, Head of Strategy & TransformationTakeda
Stephen Gibney Snr Director - DPI SaaS Quality LeadPhilips
Stephen Gibney
Snr Director - DPI SaaS Quality LeadPhilips
Azran Osman-Rani CEONaluri
Azran Osman-Rani
CEONaluri
Blaise Jacholkowski Senior Business Manager, Digital HealthZuhlke GroupOther
Other
Blaise Jacholkowski
Senior Business Manager, Digital HealthZuhlke Group
Chris Cera CEOArcweb TechnologiesHealth Tech & Solutions
Health Tech & Solutions
Chris Cera
CEOArcweb Technologies
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
Kendal Dinsmore VP, Quality Assurance / Regulatory AffairsMahana Therapeutics
Kendal Dinsmore
VP, Quality Assurance / Regulatory AffairsMahana Therapeutics
Liat Alon Country Comms & Patient Engagement HeadTakedaOther
Other
Liat Alon
Country Comms & Patient Engagement HeadTakeda
Miron Derchansky Managing DirectorBlackletter GroupOther
Other
Miron Derchansky
Managing DirectorBlackletter Group
Stephen Dunne Chief Product & Technology Officer - ManagingKoa HealthHealth Tech & Solutions
Health Tech & Solutions
Stephen Dunne
Chief Product & Technology Officer - ManagingKoa Health
Tai Chung VP of BD and Strategy, Deputy GCSempre Health
Tai Chung
VP of BD and Strategy, Deputy GCSempre Health
Vasyl Pyrozhyk Vice PresidentSMBCOther
Other
Vasyl Pyrozhyk
Vice PresidentSMBC

About this Meeting

Regulation is an absolute essential for  DTx 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 DTx product through regulatory pathways in the USA and EU? Join us in this Masterclass led by BlueBridge Technologies to learn more about:
  • The evolution of the US and EU regulatory regimes for SaMD: Key similarities and differences between regimes MDR, FDA Pre-Cert program, MDSAP 
  • What should DTx companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?  
  •  FDA Digital Health Center of Excellence (DHCoE): focus and roadmap
  • Changes expected in the US and EU regulatory regimes for SaMD in the next few years

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.

Hyve Logo

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

Important Notice on Hotel Scams

Any communication that claims to represent HLTH or any third party offering discounted hotel rooms or attendee lists is NOT AFFILIATED with HLTH and should be considered fraudulent. Please book your accommodations only through HLTH’s official channels to ensure authenticity and security.

© 2026 HLTH, INC. by Hyve Group - All Rights Reserved

About usPrivacy Policy Contact us