EPISODE 02

Regulatory as a Strategy for Healthtech

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.

Date: Friday, November 3, 2023

Time: 11:00AM – 12:00PM PST

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?