“Ready, fire, aim” is not a strategy for success. Don’t try it. The results never seem to vary.
Such observations are why John Ziobro created SpectraMedEx in 2009. After three decades of experience in the medical device industry, he has seen too many strategic misfires that left baffled company executives saying, “We never saw that coming.”
With SpectraMedEx on your side, you will never be blindsided. We bring a unique, broad-based background and perspective to your medical device regulatory compliance needs. We work with all disciplines to help them achieve full-spectrum medical excellence.
SpectraMedEx takes the fear out of medical device regulatory submissions, and instills confidence by recognizing potential pitfalls, and planning for flexibility, upgrades, and contingencies. This is also accomplished through an understanding of what constitutes a requirement, a good idea, and something that’s unnecessary.
You see, the FDA and notified bodies don’t scare us. ISO requirements don’t faze us. We know what’s required and (as importantly) what isn’t. More than 60 successful product launches are testimony.
When you want real-world, practical solutions that cover all the bases, contact us. You know your target. We’ll make sure the aim is true … and that your product hits the bull’s eye.