TIETOJA TÄSTÄ JAKSOSTA
I have seen this time and again. A medical device manufacturer follows the available FDA guidance documents, goes to the pre-submission meeting, presents their case, and leaves feeling that the meeting went well. Imagine the surprise three weeks later when the FDA sends a three-page letter advising the manufacturer to incorporate elements of the draft guidance document that the manufacturer did not even know existed. In this episode, I try to explain this concept to Joe Hage.
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HAE EDELLISIÄ EPISODEJA
Hae kanavan LeanRAQA with Michelle Lott vanhoja jaksoja.
MUITA jaksoja TÄSSÄ PODCASTISSA
Michelle chats with MDG's Joe Hage about the fast-approaching May 2020 deadline for implementation of MDR, and a possible idea for extending the deadline. Remember "meaningful use" and the eight stages with targeted implementation dates for adoption of the electronic medical record (EMR)? &nbs…
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Protective gear is in high demand, and it seems everyone is making masks. In this clip, I discuss the requirements for each type of mask, the constantly changing regulations, and the reason why that homemade mask may not offer up any protection after all.
Vastuuvapautusilmoitus: Tälle sivulle upotettu podcast ja kuvitus ovat peräisin Michelle Lott:ltä, joka on sen omistajan omaisuutta, eikä se ole sidoksissa Listen Notes, Inc:n tukemaan.
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