ייתכן שפודקסט זה לא יוציא פרקים חדשים יותר, וייתכן שחלק מקבצי השמע אינם תקינים.
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על אודות פודקאסט זה 🔗
Regulatory news, tips and information to help medical device, biotech and life science companies navigate complex regulations and find the right regulatory strategy that will pave the way to successful market entry.
תדירות עדכון:
biweekly
אורך אודיו ממוצע:
20 minutes
אנגלית
ארצות הברית
5 פרקים
מאז 22 באוקטובר 2019
episodic
הפרק החדש ביותר 🔗
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.
פרקים קודמים 🔗
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.
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.
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 advisin…
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)? &nb…
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