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Demystifying the De Novo Process

Global Medical Device Podcast powered by Greenlight Guru

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What Is a Denovo?

Rob has been working in clinical research for over a year as the regulatory affairs manager, or coming up on a year. Got experience with quality management systems and helping companies launch their first class two medical devices. The topic that we kind of have on the the docud is a denovo. To me it just means something new and innovati. So i like to think of it as, ok, if you've got this new idea, andy sketched it out o the white board. And so to me, that's when the denovo pathway might be the right choice for bringing this to market.

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