Medical Device + Cosmetics: Invention, Engineering, Prototypes.

New Technology Development = NuTecDev,LLC. WELCOME!

Dr. Dwight Back and Michele Gardill, P.E., the partners and principals of NuTecDev, LLC, have both dealt with regulatory bodies outside the US, in addition to the FDA and Health-Canada.  NuTecDev, LLC understands the process of gaining approvals, and we can match your situation with the proper Regulatory expert(s), whether you plan to launch internationally or only within one region of the globe.

Additionally, we offer technical review and guidance on your regulatory responses, so that you have confidence that your data and reports are truly ready for technical reviewers.  We understand the scrutiny that your reports may come under, so clarity is critical.

contact us to find out how we can help you..

Since cosmetics and medical devices are overlapping more and more, it is becoming increasingly difficult to categorize some of the new products coming out.  Since the regulatory requirements are very different--affecting development budgets and timelines greatly--it is worthwhile to determine your new product's category as early as possible.  With decades of experience in both cosmetics and medical devices, NuTecDev, LLC can help.

Contact us today to discuss regulations affecting your new product.

We understand that confidentiality is crucial.  Please click the button below for the Agreement:

REGULATORY FILINGS - "What to Do to Gain Approval"