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Regulatory

 We interact with the FDA and numerous other regulatory agencies on a weekly basis, making our expertise current and relevant. Our expertise, experience, and innovation are aligned and harnessed to deliver excellent guidance to your product development team in the most cost-efficient manner.

Why Choose Us

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1

Business Oriented

We understand that you want your product on the market in the fastest time with the least cost. And unlike other consultants, we understand this point of view. Our goal is your goal, your product cleared.

2

Problem Solver

We start with what is the fastest route to clearance. We don’t start with what has everyone else done. It’s our job to find a quick compliant pathway to market, not just cut and paste a one size fits all solution.

3

Budget Friendly

With Fractional Staffing, we work like we are part of your company (because we are).

 

Our alignment is exactly on your goals. We are paid on results and not on “hours”.

Services

FDA SUBMISSIONS (510K, DE NOVAS, PMAS, ETC.)

Our experts can develop your strategy, lead your product development team, advise and assist with your testing, write the submission, and interact with the regulatory agency at all levels to help provide the fastest clearances possible.

  • 510K

  • DE NOVOs

  • PMAs

Turn Your Medical Device Idea into Reality

Book your free 30-minute meeting now

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