New to Medical Device Regulation?

Consider starting with my Digital Health Regulatory Pathway Master Class series.

Whether you’re building a Software as a Medical Device (SaMD) product or an AI-enabled tool, this series breaks down the core concepts every founder should understand about US and EU regulatory pathways, from what qualifies as a medical device to how risk classification affects your timeline, cost, and market strategy.

Here’s what my Digital Health Master Class series covers:

• Post 1: Why Regulatory Strategy Can Make or Break Your Digital Health Startup
• Post 2: Medical Device 101 — What Counts, What Doesn’t, and Why It Matters
• Post 3: FDA vs. MDR – Two Very Different Worlds of Medical Device Regulation
• Post 4: How to Figure Out Your Device’s Risk Class (and Why It’s Step One)
• Post 5: What Your Risk Class Means in Practice—Docs, Costs, and Clinical Trials
• Post 6: Choosing the Right Regulatory Pathway and Market Launch Strategy

The whole series will take you about 50 minutes to read, so grab a coffee and dive in.

Another option for getting yourself oriented to the world of Med Tech and Digital Health regulations is to leaf through the slide deck below titled, “Medical Device Approval Pathways in the United States and European Union,” below.  I developed this deck to prep incoming cohorts at various incubators and accelerators.