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      Day: February 15, 2022

      15Feb
      De Novo Classification Request? We Can Help
      By Brian Buckin FDA 510(k) Submissions

      De Novo Classification Request? We Can Help

      The De Novo process is one that has not been widely used by most of the medical device industry. In 2020 there were 26 de novo requests issued, compared with…

      About

      With over 20 years of trusted experience, Empirical is your expert partner for mechanical testing, regulatory consulting, and prototyping providing comprehensive & proven solutions. We specialize in the testing of medical devices. ISO/IEC 17025:2017 Accredited.

       

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        • Regulatory & Consulting
        • European Medical Device Regulation
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        • About the Team
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      Recent Posts
      A Brief History of the Prosthetic Limb
      July 5, 2022 by socialseo
      A Brief History of the Prosthetic Limb

      By Brian Buck The briny deep is a dangerous place…

      De Novo Classification Request? We Can Help
      February 15, 2022 by Brian Buck
      De Novo Classification Request? We Can Help

      The De Novo process is one that has not been…

      The History of Spinal Surgery & Implants
      August 16, 2021 by Brian Buck
      The History of Spinal Surgery & Implants

      From a deep rooted history thousands of years in the…

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