Struggling with the right regulatory pathway for your digital health product?

You’re not alone, and you’re in the right place.

I’ve built this site for startups navigating FDA and EU MDR requirements —especially Digital Health teams working on low- to moderate-risk products.

My goal is to give you actionable, easy-to-understand guidance on some of the basic questions founders have when embarking on product development.

If you’re building in healthcare and asking questions like, “is my product even a medical device?,” “do I need a Notified Body?,” or “does my device qualify as a 510(k) product (for that matter, what exactly is a 510(K) product?”, then this space is for you.

Here, you’ll find plain-language resources to help you understand which regulatory pathways are apply to your product and the time and costs associated with market approval.  

Brand new to medical device regulations?

Check out my  Where to Start page for medical device and digital health 101 materials to get you on your way.

If you have the basics down, then you might want to check out my Deep Dives on topics that seem to come up again and again in my conversations with founders.  These are write ups of my analyses on various topics of relevance to Digital Health founders.  I also try to keep a tally on relevant news in the area, especially as applied to the US.  Check out my Digital Health News page, where I post on issues and events that are particularly relevant to US markets. Finally, I post answers to common questions I get from founders in the FAQs.