Nex-RA

Nex-RA’s experienced associates each has at least 7 years of experience in the medical device industry, and at minimum, post-graduate degrees in Biomedical Engineering, Mechanical Engineering, Regulatory Science, and other related disciplines. The majority of Nex-RA’s associates have held key positions in Regulatory Affairs and Quality Assurance with Fortune 500, mid-size, and start-up companies. Nex-RA’s US Regulatory Affairs experts each have obtained multiple 510(k) clearances for a wide variety of devices, in addition to working directly in the development and testing of new medical devices. The EU and International group has created Technical Files, Design Dossiers and have executed numerous product registrations in Europe, Japan, China, South Korea, Russia, Mexico, Canada, Brazil, Australia, the Middle East, and other major markets.

All Nex-RA associates have significant expertise in supporting Notified Body and FDA surveillance and directed audits, as well as conducting ISO 13485 quality systems audits for suppliers and mock audits for clients. Nex-RA actively engages with the top industry organizations such as AAMI, RAPS, TOPRA, ASQ, ASME, EDUQUEST and local groups throughout the major US med tech hotbeds including the SF Bay Area, Southern California, New Jersey, North Carolina, Chicago and Minnesota. Additionally, Nex-RA has a global reach with affiliates worldwide, assisting US firms with obtaining international market clearances.

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