Our success comes from hard work and good communication. We have authentic knowledge and an astounding amount of medical device development experience. We were well trained by the U.S. Department of Defense before we started medical devices.

We are at the top of our game. We have done almost every type medical device development project - under almost every possible constraint: cost, schedule, performance and recovery.


We have even rescued 510(k)s after FDA / CDRH rejection and achieved approvals. We have done it all. You will not find anyone better at any price. When we won the first CDRH appeal, they did not even have a system to re-instate the 510(k). We do not pretend to have special friends at the FDA - we rely on good science, high-performance and hard work.


Advice is often -fraught with misrepresentations, misnomers, exaggerations and outright deceit. We will only offer you integrity, honest appraisals, real prices and the truth at every interval. We bring you -good news and bad news at equal speed. You will receive from us what you expect- and more!