این پادکست ممکن است دیگر قسمت های جدیدی را منتشر نکند ، و ممکن است برخی از فایلهای صوتی خراب شوند.
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درباره این پادکست 🔗
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.
فرکانس به روز رسانی:
biweekly
میانگین طول صدا:
20 minutes
انگلیسی
ایالات متحده آمریکا
5 قسمت
از سال 22 اکتبر 2019
episodic
آخرین اپیزود 🔗
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.
جستجوی اپیزودهای گذشته
اپیزودهای قبلی LeanRAQA with Michelle Lott را جستجو کن.
اپیزود قبلی 🔗
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 advising…
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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سلب مسئولیت: پادکست و آثار هنری تعبیه شده در این صفحه متعلق به Michelle Lott است که متعلق به صاحب آن است و به Listen Notes، Inc وابسته یا تایید نشده است.
موتور جستجوی پادکست
می توانید از وب سایت ما برای جستجوی پادکست های3,823,974و قسمت های195,697,468بر اساس افراد، مکان ها یا موضوعات استفاده کنید.
سرمایه‌گذاری روی دانش بیشترین بازده را دارد؛ پس پادکست گوش می‌دهم.
‐ Benjamin "Llamacorn" Franklin
جستجوی اپیزودهای گذشته
اپیزودهای قبلی LeanRAQA with Michelle Lott را جستجو کن.
مدعی این پادکست شوید
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