What we Do

Nu Device Consulting is dedicated to helping medical device manufacturers sell their products. Our target market is small-to-medium sized companies located outside of the US, but services are also offered to US entities of any size. Primary activities are helping customers satisfy regulatory requirements at the US Federal level and state levels. This includes dealing directly with the regulatory agency on your behalf as well as making sure you are aware of current regulatory requirements and recommendations. Services are also offered in getting insurance reimbursement codes where applicable and locating qualified distributors for your product.

How we're Different

What sets Nu Device Consulting apart from other companies providing regulatory services? For starters, a strong background in engineering. Understanding the client's product is key to communicating with your company at the levels needed to ensure compliance. We understand manufacturing and can translate the regulations into terms that your people understand. Our mission is to be more than a vendor, we are in your corner. And if you are not in the US, choosing Nu Device Consulting LLC to manage the business of getting your device to market is the next best thing to being here yourself. You'll find bigger consulting agencies, but you won't find anyone more responsive.

Why Choose Nu Device

Why choose Nu Device Consulting to handle your regulatory affairs? Perhaps your company is just getting started, and does not have the resources to hire a full-time regulatory affairs specialist for medical devices. Or your company is not in the US and has no plans to open a US office. Or your company is large and located in the US, but you are currently without a regulatory affairs specialist and need 510(k) submissions to be taken care of now and not when you finally find someone with both engineering and regulatory experience to fill that position.

Our Partners

Dymedso Inc. EndoLab MESA DI SALA GIACOMO & C. S.N.C.

1600-G Golden Horseshoe Circle, Morrisville NC 27560

Tel: (919) 208-1953 Fax: (919) 249-8953

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November, 2018. All rights reserved.