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After spending nearly two decades as a metallurgist doing research for aerospace applications, in the 1990s Dr. Bigoney became involved with materials used in implants. As a titanium specialist, she worked together with surgeons to improve materials and surface treatments for biomedical implants, including artificial hip and knee joints, plates and screws for maxillofacial reconstruction, and dental implants, focusing on the issue of wear debris. She was instrumental in initiating a concentrated research effort on the "Interface between Material and Biosystem" (SPP 1100) of the German Research Society. She has authored or co-authored several joint publications with physicians, including:

In the late 1990s, Dr. Bigoney was part of an interdiscplinary development team working with a small company located in Bavaria to develop a novel replacement knee joint.

Upon her return to the US in 2002, Dr. Bigoney registered as a US Agent with the FDA and began helping the enterprises she had been involved with in Europe bring their innovations to the US market. Almost immediately she was contacted by companies located in Canada who needed assistance with their regulatory needs. Over the next several years, Dr. Bigoney prepared and submitted 510(k) applications on behalf of clients in Europe and Canada. With the founding of Nu Device Consulting LLC in 2011, Dr. Bigoney is now assisting US customers in addition to her foreign customers.

Dr. Bigoney is a member of the Regulatory Affairs Professional Society and holds a current US Regulatory Affairs Certification.

2029 Weston Green Loop, Cary NC 27513

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