EU MDR | FDA 510(k) | ISO/IEC 23894 | ISO/IEC 42001 Consultant

I've spent years helping startups and SMEs work through some of the more demanding regulatory frameworks out there; FDA 510(k), EU MDR, and more recently the EU AI Act.

Most of my clients come to me when they're staring down a regulatory requirement they're not sure how to approach. We work through it together, from figuring out the right pathway to getting the documentation and processes in place to actually meet it.

On the medical device side, I support teams with 510(k) preparation, EU MDR compliance, technical file readiness, and regulatory strategy for Software as a Medical Device. On the AI side, I help organizations understand what the EU AI Act actually means for their product and what they need to do about it.

I've supported clients through to successful outcomes across all three frameworks and if you're early-stage trying to figure out where to start, or further along and need someone to get your submission across the line.

Happy to talk.