Nu Device LLC was founded in 2011 to handle the growing volume of business dedicated to medical device regulatory consulting that was being carried out at Springfield Metallurgical Services, Inc.. Founded in 2002, Springfield Metallurgical Services, Inc. has been performing testing, analysis and consulting for manufacturers and users of metals and alloys. Medical device regulatory consulting grew out of the involvement with product development for hip and knee implants.

Jean Bigoney has been registered as a US Agent with the FDA since 2002 and is currently acting as a US Agent for customers in Canada and Germany. Successful 510(k) applications have been written for a range of devices including electronic Class II devices and combination products.

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.