I help in-house software managers build processes that satisfy regulators and stay on schedule
I help software teams navigate IEC 62304 compliance and FDA regulatory requirements while integrating AI into development workflows. My work centers on building practical SDLC processes that reduce bottlenecks and keep projects on track.
This is a conversation, not a quick fix. In 30 minutes I want to understand what's actually going on: an upcoming FDA submission, an IEC 62304 gap, a CSA question, an audit finding. No charge, no obligation. If there's a real fit, I'll follow with a short written proposal covering scope and timeline for closing the gap.
For teams that want more than a conversation before committing. Three hours on your highest-risk gap, one sitting. You leave with a written summary of findings, not a sales pitch. Every full engagement starts with a Tier 0 assessment, so if you move forward within 3 months, the $300 is credited in full toward whatever tier you book.