Episode 02

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.

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?