We help medical device companies decide how to reach the market, then support the submission. The work covers submission strategy, predicate assessments, and pathway decisions for market entry across FDA, EU MDR, and global markets.
The pathway decision comes first and costs the least to get right. A predicate assessment tests whether the device you want to clear really is substantially similar to the one you are pointing at, before you build a submission on that claim.
Strategy also sets the evidence you need, in what order, and what a reviewer is likely to question. It is cheaper to answer those questions in the plan than in a deficiency letter.
We build timelines you can plan around and plan for post-market surveillance, so the work does not end at clearance.
When to call us
- “Our 510(k) strategy needs a second opinion.”
- “Our EU MDR plan is sketched on a whiteboard.”