Bowline Group provides FDA regulatory strategy, quality systems, and post-market compliance consulting built specifically for lean SaMD teams — plus GAMP 5-validated software tools for the workflows many companies are still doing manually. Whether you're building your compliance infrastructure from the ground up or your regulatory program has started to drift and needs a course correction, Bowline brings tried and tested expertise scoped to what you actually need to solve.

Bowline Group was founded by Rachel Hofmann, a QA/RA professional with fifteen years in SaMD spanning greenfield and brownfield QMS implementation, AI tool integration, ISO 13485 certification, Q-Subs, 510(k) submissions including PCCPs, Breakthrough Device Designations, and FDA inspection and third-party audit leadership. She built Bowline Group because lean teams deserve a real ally in their corner — not a one-size-fits-all approach or a consultant who shows up with a binder and bills by the page.