À PROPOS DE CET ÉPISODE
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three weeks later when the FDA sends a three-page letter advising the manufacturer to incorporate elements of the draft guidance document that the manufacturer did not even know existed.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.
Anglais
États-Unis
TRANSCRIPTION 🔗
Are you the producer of this podcast?
Add a podcast transcript
Need Audio-to-Text?
Transcribe with Listen411 in Just 60 Seconds
RECHERCHER LES ÉPISODES PASSÉS
Rechercher les épisodes précédents de LeanRAQA with Michelle Lott.
AUTRES ÉPISODES DANS CE PODCAST
MDR, MDD, nasal cannulas and the PIP patient safety breakdown - we covered it all at the southern California meeting of the Opthalmic World Leaders (OWL) group. Join me and Greg Kunst as we talk regulation, clinical validation testing and industrial-grade silicone.
Michelle and Greg talk the technology benefits of launching in Europe, the lack of assessment panelists and the challenges of translating MDR into multiple languages without losing (or changing!) the intention in this second installment from the presentation with the southern California OWL group.
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.
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…
Avertissement: Le podcast et les illustrations intégrés sur cette page proviennent de Michelle Lott, qui est la propriété de son propriétaire et n'est ni affilié ni approuvé par Listen Notes, Inc.
MODIFIER
Merci de nous avoir aidé à tenir la base de données de podcasts à jour.
