Our founding team spent years working in-house at medical device startups and mid-sized companies—navigating FDA submissions, building quality systems from scratch, and running clinical trials on tight timelines and tighter budgets.
We saw firsthand how hard it was to get the support we needed. Large CROs quoted $1.5M+ and 18-month timelines. Solo consultants could help with one piece but couldn't scale. We ended up managing 5 different vendors just to get through a single 510(k).
Prime Path was founded to be the partner we wish we'd had—an integrated team that could handle regulatory, quality, and clinical work with the speed and flexibility lean MedTech teams actually need.




.png)



Whether you're planning your first 510(k) or scaling to commercialization, let's talk about what you actually need.
Book a Discovery Call