I help early-stage SaMD startups (post-seed to Series A) build FDA-ready quality systems without killing their development velocity.  Most digital health founders postpone regulatory planning until investors or the FDA force their hand, then they’re scrambling to organize scattered requirements, informal testing, and zero design controls into a compliant QMS.  I’ve been there. As Quality Engineering Manager at Woebot Health, I took the team from scattered documentation to ISO 13485 certification while maintaining startup speed. Now I help other early-stage teams do the same: establish design controls, traceability, and V&V frameworks that clarify product decisions instead of burying them in paperwork.  If you’re building a SaMD and wondering when/how to tackle regulatory compliance, let’s talk!