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Demystifying the De Novo Process

Global Medical Device Podcast powered by Greenlight Guru

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What's the Quality Management System for a Novel Device?

"To me it is a very similar es for any submission. You're goin to be wanting to, you know, again, get those get the quality management system in place," he says. "If you've got a good unow product development process, you know it's going to lead to getting everything that you need."

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