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Michelle Lott Podcasts

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Flicker Effect

David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

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Flicker Effect is a weekly podcast that takes a look at all that is movies. David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard discuss, analyze, and maybe sometimes obsess over the latest in movies, TV, and pop culture.
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How-To Dragon Con 2024 - with Charles McFall 2:02:49

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Charles McFall is joining us for this year's edition of How-To Dragon Con. Charles is the Track Director of the Digital Media Track and was recently names an official spokesperson for Dragon Con! Dragon Con is a pop culture convention held each Labor Day Weekend in Atlanta, GA. In this episode we share our tips for attending 5 day extravaganza. Mak…
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A Conversation with Vistatec's Life Science In-Focus Podcast 21:22

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The good folks at Vistatec invited me to participate in their Life Science In-Focus podcast last month, where host Karen Tkaczyk and I chatted about the intricacies of regulatory affairs within the life sciences.We also discussed just how I ended up in the field, and the many challenges companies face when choosing regulatory pathways in the United…
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eSTAR 5.0 - What You Must Know 32:58

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This is not last year's eSTAR - a LOT has changed, and there are things you need to know before you try to submit your 510k. In this episode, we'll guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for those of you planning a 510k or PMA submission.We'll review the eSTAR 5.0 platform and what you need to know to use it eff…
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Fractional or Full Time Quality Support: Which is Right for You? 22:49

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When is it better for a medtech startup to hire a fractional quality professional, and when is it time to hire full-time? This is not necessarily an easy question to answer, and there can be a lot of factors impacting the decision. In this joint podcast with Mitch Robbins, we discuss the challenges and opportunities of today's topsy-turvy QA hiring…
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Medical Devices, Cloud Computing and Cybersecurity with Randy Horton 27:56

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As medical devices become more connected, concerns about security increase, leaving manufacturers - and regulatory staff - uncertain as to the best path forward. Listen in as Michelle and guest Randy Horton discuss industry needs and what the FDA plans to do to ensure the safety of connected and AI-driven devices.…
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How To DragonCon 1:10:22

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This week, Dave and Michelle discuss DragonCon, the annual sci-fi convention held in Atlanta, GA. After a few years of experience, they share their tips for attending the pop culture extravaganza! Official Website: https://www.dragoncon.org/ Dragon Con Rooms Group: https://www.facebook.com/groups/dragonconroomsgroup Learn more about your ad choices…
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The Joy of Document Control 15:29

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You may think document control is boring, but wait until you hear these stories:Red-lined post-it notes. Uncontrolled copies passed around during inspections. Master files stored on a desktop instead of in the eQMS system. Secret file cabinets in locked closets full of uncontrolled, red-lined specifications documents.Oh, the joy of document control…
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Barbenheimer Review 1:23:53

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After a bit of a delay due to San Diego Comic-Con, we have finally seen both Barbie and Oppenheimer and it's time to discuss! Dave, Bobby, and Michelle review the films spoiler-free, and also talk Barbie spoilers at the end of the episode. YouTube Video: https://youtu.be/RcvLeTTvH7c Learn more about your ad choices. Visit megaphone.fm/adchoices…
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Make Quality Make $en$e: Management's Role in Quality 37:27

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The best leaders know that quality is much more than a box to be checked, or a necessary evil to be endured along the road to FDA (or MDR) approval.This is the third in a series of conversations talking about quality and how it can actually benefit a company, and even give you an advantage over your competition.…
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Loki S2 and Echo Release Dates, Mission: Impossible Dead Reckoning Trailer 59:37

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This week we discuss the latest Loki season 2 and Echo news, the new Mission Impossible: Dead Reckoning Trailer, the closing of Star Wars: Galactic Starcruiser, and more. Flicker Effect on Twitch: https://www.twitch.tv/flicker_effect Flicker Effect on YouTube: https://www.youtube.com/flickereffect Learn more about your ad choices. Visit megaphone.f…
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MDR By The Numbers: Leveraging New Data for Implementation Planning 1:18:00

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MDR has been puzzling me for a few years now, and it's getting worse, not better. In this webinar hosted by Greenlight Guru, we look at the data gathered from recent MDCG guidance documents, industry and notified body surveys, and personal interviews with stakeholders (including notified bodies) who shared their first-hand experiences with implemen…
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EUDAMED Update: January 2023 51:47

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Upload to EUDAMED is a requirement of MDR, but adoption has been slower than anticipated. Manufacturers are reluctant to invest in the time required to upload their product catalog, and the platform itself has been plagued with issues. Listen in as Richard Houlihan lifts the curtain on why industry has been reluctant to embrace EUDAMED and what the…
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From the Front Lines of EU Medical Device Regulation 1:00:55

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What happens when two regulatory consultants sit down for a chat about MDR?A lot of distressed head shaking, for sure and an equal measure of what-were-they-thinking eye rolls, but we also dug into the meat of the proposed extension and what it might mean for industry.Monir El Azzouzi and I chatted last month about MDR, and while we didn't solve al…
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Risk Management - Beyond the Basics 54:31

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Risk management can be difficult to understand, even for seasoned quality and regulatory professionals, because there are SO. MANY. ACRONYMS.I mean, there's FMEA, uFMEA, ISO, FDA, PMA to name a few.We discussed acronyms and more at the November meeting of the Dallas ASQ - Section 1402, so if you're ready to go beyond the basics and right into the v…
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Trends in FDA Initiatives and the Impact on Orthopedic Devices 38:14

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Orthopedic devices may qualify as medical devices, but they have very different regulatory requirements. So different that the FDA created a new office to manage orthopedic devices - the Office of Science and Engineering Laboratories (OSEL) - and ensure their safety and efficacy. OSEL was created to accelerate patient access to innovative devices, …
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Usability Testing and the FDA 32:35

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Do you know how your end users will use your device? Are you sure?Do you know how end use will differ between demographic groups? Do you know why this is important, and how usability testing fits into your risk assessment?Shannon Clark has been doing human factors/usability testing for some time, and she can tell you exactly why usability testing i…
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