RockHealth’s FDA Guide For Digital Health Entrepreneurs

Mitchell Posada

RockHealth recently published a great guide on how to navigate the FDA for the emerging wave of digital healthcare innovations including mHealth apps.  It is especially useful for any team member of an early-stage startup that may not be familiar with the FDA regulatory environment.   I liked the simple and succinct examples provided from classification to 510(k) premarket submission to post-market recommendations.

FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health from Rock Health

If you are in a healthcare startup keep on eye on this blog (there are a bunch of posts related to FDA) and or visit our SlideShare presentations.

Orthogonal also runs the Chicago Lean Startup Circle whose mission is to teach lean startup methods and provide support and mentoring to Chicago’s startup community.  There are over 3,000 members and it’s our third year of running the Chicago Lean Startup Challenge.  This year we’re adding a healthcare track.

What other information would be useful to your Healthcare Startup?  Send us a note.  If you want to learn about Orthogonal’s healthcare software and mobile app development services stop by here.

Related Posts

Talk

Gathering Medical Device Data & Evidence: Webinar

White Paper

Software as a Medical Device (SaMD): What It Is & Why It Matters

Talk

What Medical Device Software to Develop Under QMS: Webinar

Article

SaMD Cleared by the FDA: The Ultimate Running List