Good science ensures fast FDA "approvals"

Fast approvals are the result of quality applications - based on addressing the issues and supported by tests. Good science gets you there faster... without reversals, without re-dos and without surprises. We always develop and face major project issues - first. We preach that true professionals are seldom surprised by unanticipated issues.

Our history is development engineering

We are not QC inspectors who've matured into regulatory affairs professionals. When the Cold War ended and Department of Defense contracts expired, we moved into medical electronics. As part of those projects, we found more and more clients asking us to get their device through the FDA 510(k) review cycle.

We are hard-core, heavy-duty, "get your hands dirty", "in the lab", development engineers. That is how we approach your project! We know how to specify, design, prototype, test and deliver complex medical systems and the essential documentation (that without such - reflects as an ill conceived medical device). This means we can work at any level in your medical device project, and we do our part to create a winning FDA 510(k) application.