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14 Feb 2022 | 03:45 PM GMT

Masterclass: The regulation of SaMD in the US

Anchored by:

Bernhard Kappe
Founder & CEO
ORTHOGONAL
Clay Anselmo
VP Quality Assurance and Regulatory Affairs
SHRINER AND ASSOCIATES

Participants:

Bernhard Kappe Founder & CEOOrthogonal
Bernhard Kappe
Founder & CEOOrthogonal
Clay Anselmo VP Quality Assurance and Regulatory AffairsShriner and Associates
Clay Anselmo
VP Quality Assurance and Regulatory AffairsShriner and Associates
Adam Samson President, National Center Clinical TrialsAdvocate Health
Adam Samson
President, National Center Clinical TrialsAdvocate Health
BB
Brian Binkowski Director of QualityTwill
BB
Brian Binkowski
Director of QualityTwill
Cathy Zaremba Director, Product MarketingBrightInsight
Cathy Zaremba
Director, Product MarketingBrightInsight
Dorothy Hoffman Exec Dir, Head of Global ImmunologNovartis
Dorothy Hoffman
Exec Dir, Head of Global ImmunologNovartis
Gandolf Finke CEOSynagen
Gandolf Finke
CEOSynagen
Ivan Jurisic Head of ProductPatients Influence
Ivan Jurisic
Head of ProductPatients Influence
Jo Masterson CEO2Morrow, Inc.
Jo Masterson
CEO2Morrow, Inc.
Krys Zaluski Director, External GrowthBiogen
Krys Zaluski
Director, External GrowthBiogen
Randy Horton VP of Solutions and PartnershipsOrthogonal
Randy Horton
VP of Solutions and PartnershipsOrthogonal
Smit Patel AdvisorEconomist Impact
Smit Patel
AdvisorEconomist Impact

About this Meeting

Regulation is an absolute essential for companies who want to get their SaMD accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your SaMD through regulatory pathways in the US? Join us in this US-focused Masterclass led by Clay Anselmo and Bernhard Kappe. They will walk us through: 

  •  Current status of SaMD regulation: what does the regulation of SaMD look like? Why is it so challenging to regulate and how is the FDA responding today? 
  •  Understanding the existing regulatory pathways: what should digital health companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?  
  •  Regulatory Innovation at the FDA and its impact on SaMD:  What will the regulation of SaMD look like in the next few years?  What pilots are under testing, evaluation or discussion (e.g. FDA Pre-Cert Program, framework for GMLP, software change management etc)? 
  •  Recommended approach to use today for developing, launching and evolving SaMD under current regulatory frameworks and guidance.