MDisrupt is proud to present a multi-part webinar series that explores the major steps to building digital health solutions from inception to adoption featuring some of the industry’s leading experts.

Episode 02

Regulatory as a strategy for healthtech

In episode two, we’ll cover:

  • Regulatory terms 101 (LDT, 510K, analytical validation, clinical validation SAMD, intended use).
  • When is it wellness versus enforcement discretion versus medical device?
  • What is the process for getting a regulatory clearance? How long does it take? How much does it cost?
  • What studies do I need to do and how should I start them?

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Episode 01

Solve a real clinical problem

In episode one, we’ll cover:

  • The top problems health systems face
  • What a digital health company should do BEFORE approaching a health system
  • What it takes to get a provider to adopt
  • What health systems are looking for in digital health solutions

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