You’re a visionary entrepreneur whose brilliant invention has the potential to improve the lives of millions…
The dreaded…
FDA Approval Process.
If you’ve never taken the pilgrimage before, you might not truly appreciate how treacherous it is. Full of red tape, fine print and nearly impossible-to-follow procedures, it wasn’t designed to help you get your invention to market. It was designed to make sure you DON'T get to market unless you meet the highest standards of quality and safety.
We geek-out on safer products and successful launches. We’re your expert guides to doing this the right way, the first time, eliminating the risks for you and your investors.
Head Fanatic!
Dr. EDIUSKA LAURENS,
M.S., EngD
Medical Device Regulatory, Quality, Product Development Expert
Former Stryker Executive
