Dave and Michelle discuss last weekend's DragonCon and review Beetlejuice Beetlejuice. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Our live panel from Dragon Con 2024! Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

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…

The gang is all back together to chat about the biggest announcement from SDCC and to review Deadpool & Wolverine. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Dave and Michelle chat live during the Marvel Hall H panel to discuss all the big news from this year's SDCC. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

In this episode, Dave and Bobby discuss Longlegs and the series finale of The Acolyte. 00:00 Intro 00:50 Russo Brothers News 06:31 Longlegs 18:21 The Acolyte Episode 8 Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

This week, The Acolyte is back with another episode and this was fans in a frenzy! Now it's our turn to discuss. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

This week we finally have new Star Wars content to dig into! The first two episodes of The Acolyte are here and we share our thoughts both spoiler free and spoiler filled (with plenty of warning). Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

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…

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…

This week we review Civil War, the latest film from writer/director Alex Garland. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

David and Bobby discuss some of the big news from this year's CinemaCon. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

David, Bobby, and Michelle review Ghostbusters: Frozen Empire. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

The trailer for the next Star Wars show is finally here! In this episode we share our thoughts on our first look at The Acolyte as well the latest trailer for Furiosa: A Mad Max Saga. And there is a rumor going around that the next James Bond has been picked. 🤔 Learn more about your ad choices. Visit megaphone.fm/adchoices…

David, Bobby, and Michelle discuss this years Oscars. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Why would you use a 3rd party reviewer for your submission? How does a 3rd party reviewer function? How is it different from working with the FDA?I sat down with my good friend Shawnnah Monterrey from Beanstock Ventures to answer all your pressing questions about using 3rd party reviewers.โดย Michelle Lott

Dave, Bobby, and Michelle discuss Dune Part 2. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Question, questions, everyone has questions about eSTAR 5.0, so I sat down with the FDA's Patrick Axtell to answer the most pressing ones I've received.From file size to eSTAR type to biocompatibility - we cover it all.โดย Michelle Lott

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…

It's been while! We are back after a break to catch up and get the ball rolling again. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

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.…

David, Bobby, and Michelle discuss The Fall of the House of Usher. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Dave, Bobby, and Michelle discuss the finale to season 1 of Ahsoka. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Dave, Bobby, and Michelle discuss Ahsoka episode 6. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

The 5th episode of Ahsoka is now on Disney+ and to say the reaction has been positive is an understatement. But do Dave and Bobby share in everyone's excitement? Check out this episode to find out! Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Dave, Bobby, and Michelle discuss the first 2 episodes of Ahsoka. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

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…

Many manufacturers see quality as a necessary evil, a box to be checked just to placate the FDA on the way to market launch. But it can be SO much more.In this episode, Ti Benson and I discuss how quality can actually be a business benefit and not simply something to be endured.โดย Michelle Lott

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…

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…

The Flicker Effect crew reunited at San Diego Comic-Con and it's time to discuss the very interesting experience of this year's convention. With actors and writers on strike, how different was SDCC? Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Dave, Bobby, and Michelle discuss Mission: Impossible - Dead Reckoning Part One. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

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.…

Dave, Bobby, and Michelle review Indiana Jones and the Dial of Destiny. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Dave, Bobby, and Michelle discuss some Superman: Legacy casting news, the lack of big studio presence at the upcoming San Diego Comic-Con, The Flash, Elemental, and more. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Dave and Michelle share their thoughts on The Flash and discuss the first reactions to Indiana Jones and the Dial of Destiny. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Dave and Bobby discuss the Apple Vision Pro announcement and Bobby reviews Spider-Man: Across the Spider-Verse and Transformers: Rise of the Beasts. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Dave, Bobby, and Michelle discuss a question: Should movies tell if they are actually part 1 of 2 movies (or more)? Or do we like the surprise? Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

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…

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…

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…

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…

The crew continue their look back at the films of 2022 with their honorable mentions, most disappointing film, films they wish they saw, and more. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

David, Bobby, Jascha, and Michelle countdown their top 10 films of 2022. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

David and Michelle discuss Glass Onion and Babylon. Timestamps: Glass Onion Review ~00:03:20 Babylon Review ~00:19:20 Babylon SPOILERS ~00:38:30 Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

After a 13 year wait, the time has finally come for a sequel to Avatar. In this episode, David, Bobby, and Michelle discuss Avatar: The Way of Water. Learn more about your ad choices. Visit megaphone.fm/adchoicesโดย David Lott, Bobby Jackson, Jascha Wilson, and Michelle Hillard

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…

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, …

There's the pre-submission, of course, but did you know there are other ways to get FDA feedback without breaking the budget? In this episode, Michelle reviews three pathways that can help startups save some cash while working their way through the commercialization process.โดย Michelle Lott