Most early-stage medical device companies cannot afford a permanent head of quality, and cannot afford to be without one. We embed fractional quality assurance and regulatory affairs (QA/RA) support on your team, so you get senior judgment without the full-time cost.
We set the quality strategy early, through the 510(k) and first launch, so what you build in the first year is something you will not have to rebuild in the third.
Because we work as part of your team, we see the decisions as they happen and can steer them.
When you outgrow the arrangement, we can help you hire your first quality leader and hand over cleanly.
Twenty-five years of quality work tells us early what a regulator will ask for, so a small company does not learn it the expensive way.
When to call us
- “We are pre-510(k) and need a quality strategy without hiring a vice president of quality yet.”