درباره این پادکست 🔗
Podcast by Michelle Lott
میزبان‌ها:
فرکانس به روز رسانی:
weekly
میانگین طول صدا:
32 minutes
مصاحبه های مهمان
انگلیسی
ایالات متحده آمریکا
93 قسمت
از سال 18 سپتامبر 2018
episodic
آخرین اپیزود 🔗
Brilliant technology is not enough.
In this episode, Renae Franz unpacks the realities of medical device commercialization — including regulatory strategy, reimbursement, clinician adoption, usability, and market validation.
Through real-world medtech case studies, the conversation examines why tec…
جستجوی اپیزودهای گذشته
اپیزودهای قبلی RAQA Today را جستجو کن.
اپیزود قبلی 🔗
Most medtech teams underestimate the work before FDA submission—and overestimate what happens after clearance.
In this episode, regulatory expert Michelle Lott, commercialization strategist Renae Franz, and reimbursement specialist Fernanda Nusbaum unpack the leadership blind spots, strategic mis…
A practical, lightly spicy guide to becoming the regulatory person teams actually respect—and want in the room.
Learn how regulatory and quality professionals can build trust, lower resistance, and communicate across cross-functional teams without becoming the “department of no.” This episode cove…
Because your QMS should be a safety net—not a set of handcuffs.
In this episode of Device and Conquer, Michelle and Ti break down how to build a quality management system (QMS) that doesn’t suck—or suck the life out of your MedTech team.
From the shift to FDA’s new QMSR aligned with ISO 13485:201…
If you’re thinking about investing in medtech, congratulate yourself—you’ve chosen one of the most exciting, innovative, and occasionally stomach-churning sectors out there.
But between regulatory hurdles, clinical workflow quirks, and the fact that even great ideas can wither in the wild, medtech…
Choosing a predicate device can make—or break—your 510(k) submission, so it's important to choose wisely.
In this episode of Device and Conquer, Michelle Lott and Ti Benson break down one of the trickiest parts of the FDA clearance process: how to select a predicate that passes the “substantial eq…
Building a 510(k) isn’t just about filling in forms — it’s about telling the FDA a story they can’t say no to.In this episode of Device & Conquer, Michelle Lott and Tianna Benson unpack what really goes into preparing an FDA 510(k) submission — from substantial equivalence and predicate devices…
The FDA pre-submission (Q-Sub) process can save you time — or sink your submission. In this episode of Device and Conquer, Michelle Lott and Tianna Benson explain how to Pre-Sub like a pro.
They explain when to use a pre-sub, how to structure your questions, and what to expect from FDA’s new eSTAR …
The FDA state of the union in 2025 - deregulation, QMSR, and a toilet paper shortage?
Listen in as Michelle Lott and Tianna Benson tackle the wild world of FDA policy shifts and what they mean for medical device manufacturers. From the administration’s sweeping deregulation mandates to the long-awa…
Think you speak English? The FDA might disagree.
In the Season 2 kickoff of Device &Conquer, hosts Michelle Lott and Tianna Benson break down the unique language of the U.S. Food and Drug Administration — a dialect every medtech professional needs to understand to survive regulatory conversatio…
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 های3,824,022و قسمت های195,708,739بر اساس افراد، مکان ها یا موضوعات استفاده کنید.
If I have seen further than others, it is by listening to podcasts and standing upon the shoulders of
giants.
‐ Isaac "Llamacorn" Newton
جستجوی اپیزودهای گذشته
اپیزودهای قبلی RAQA Today را جستجو کن.
مدعی این پادکست شوید
Why to claim podcasts?
If you are a podcaster, the best way to manage your podcasts on Listen Notes is by claiming your Listen Notes
podcast pages.
It is a great, free way to engage the podcast community and increase the visibility of your podcasts.
After claiming your Listen Notes podcast pages, you will be able to:
✓
Manually refresh the RSS feed to sync up
✓
Get a verified badge (
✓
) alongside with your podcast name on Listen Notes
✓
Post آگهیهای طبقهبندیشده for sponsorship,
guests, co-hosts,
cross-promotion...
✓
Respond to listener comments on Listen Notes
✓
Use speech-to-text techniques to transcribe your show and
edit transcripts
✓
Improve the presence of your podcasts, e.g., self-service
مصاحبه با پادکستر...
✓
If you share your Listen Notes page and at-mention @ListenNotes
on X (formerly Twitter),
حساب رسمی X ما (که قبلاً Twitter بود) will retweet to promote
your show to our followers.
Coming soon:
◯ Self-service promotion on Listen Notes
◯ Track your podcast stats on Listen
Notes, e.g., listens, page
views...
◯ Manage episodes
ویرایش
از کمک شما برای بروز نگهداشتن پایگاهدادههای پادکست سپاسگزاریم
