Creative Success = Financial Balance with Flexible Budget Plans As a creative individual, dealing with irregular income can be daunting. In this episode of From "Creative Passion To Profit", titled "How Creatives Can Budget for Regular Income," I, Mahmood, tackle one of the biggest challenges faced by those in the arts and creative world—budgeting. Have you ever felt the high of being fully booked and having commissions flying off the shelves, only to be met with silence and income droughts the following month? You're not alone. But here's the good news: with a little planning, you can smooth out those financial ups and downs. In this episode, I'll share three simple steps to help you build a budgeting system that fits your lifestyle and supports your creative ambitions. You'll learn how to determine your essential baseline expenses, create a financial buffer for quiet months, and implement a flexible yet simple budgeting method that allows you to thrive creatively and financially. You'll also have some homework tasks... Timestamped Summary: [00:00:00] Introduction to challenges of budgeting with erratic income. [00:00:58] Step 1: Determine your baseline expenses. [00:02:12] Step 2: Build a financial buffer for quieter months. [00:03:46] Step 3: Apply a simple, discipline-based budget system. [00:04:58] Homework: Calculate baseline expenses and track income. Mentioned in this episode: Training Training Training Find out more about Budgetwhizz Find out more about Budgetwhizz Budgetwhizz…
Podcastok, amelyeket érdemes meghallgatni
SZPONZORÁLT
Podcast by Michelle Lott
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RAQA Today
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1
EU Hot Takes: MDD vs MDR featuring Etienne Nichols and Karandeep Singh Badwal
45:12
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45:12Podcast of a July 2024 webinar event presented by Etienne Nichols and Greenlight Guru and featuring Karandeep Singh Badwal𝗖𝗵𝗮𝗽𝘁𝗲𝗿 𝟭: 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻 𝘁𝗼 𝗘𝗨 𝗠𝗗𝗥 𝗮𝗻𝗱 𝗜𝘁𝘀 𝗜𝗺𝗽𝗮𝗰𝘁 This chapter provides a general introduction to the EU Medical Device Regulation (MDR) and its significance in the medical device industry.Key Points:The MDR is a comprehensive re…
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1
Biocompatibility for MedTech Professionals
52:21
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52:21Everything you need to know about biocompatibility - in one podcast.From a webinar hosted by MedTech Leading Voice and featuring Michelle and Marina Daineko from Intrinsic Medical Group.𝗕𝗶𝗼𝗰𝗼𝗺𝗽 𝟭𝟬𝟭: 𝗙𝘂𝗻𝗱𝗮𝗺𝗲𝗻𝘁𝗮𝗹𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗣𝗿𝗼𝗳𝗲𝘀𝘀𝗶𝗼𝗻𝗮𝗹𝘀 By understanding biocompatibility and following best practices, manufacturers can ensure the safety and efficacy…
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1
CE Certification vs FDA Submission Strategy: Which is Right for You?
49:45
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49:45Which market is best for your product - the EU or the US?The answer is not always straightforward, but Ronald Boumans, Nika Mendelev and I did our level best to answer your questions in this Master Class presentation.Michelle leads off with a review of FDA strategies and pathways.15:34 - Ronald dives into the particulars of MDR and dealing with not…
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1
ASCA, CLAP, Fraudulent Biocompatibility Data and You
30:07
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30:07Biocompatibility testing is hot right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data. Some unethical third-party testing labs are sending their clients data mined from old 510(k) submissions - and passing it off as fresh data.So what's a medical device manufacturer to do? That was the topic of…
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1
A Conversation with Vistatec's Life Science In-Focus Podcast
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21:22The 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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1
eSTAR 5.0 - What You Must Know
32:58
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32:58This 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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1
The Benefits of 3rd Party FDA Reviewers
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37:06Why 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.Michelle Lott által
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1
eSTAR 5.0 Q+A with Patrick Axtell from the FDA
33:52
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33:52Question, 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.Michelle Lott által
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1
Fractional or Full Time Quality Support: Which is Right for You?
22:49
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22:49When 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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1
Medical Devices, Cloud Computing and Cybersecurity with Randy Horton
27:56
27:56
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27:56As 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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1
The Business Benefits of Quality
12:12
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12:12Many 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.Michelle Lott által
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RAQA Today
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1
The Joy of Document Control
15:29
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15:29You 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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1
Make Quality Make $en$e: Management's Role in Quality
37:27
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37:27The 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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1
MDR By The Numbers: Leveraging New Data for Implementation Planning
1:18:00
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1:18:00MDR 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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1
EUDAMED Update: January 2023
51:47
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51:47Upload 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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RAQA Today
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1
From the Front Lines of EU Medical Device Regulation
1:00:55
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1:00:55What 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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RAQA Today
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1
Risk Management - Beyond the Basics
54:31
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54:31Risk 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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RAQA Today
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1
Trends in FDA Initiatives and the Impact on Orthopedic Devices
38:14
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38:14Orthopedic 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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RAQA Today
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1
Free FDA Communications with the FDA? What you Need to Know
50:09
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50:09There'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.Michelle Lott által
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RAQA Today
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1
Split Personalities of QMS Audits for FDA, MDSAP and ISO 13485
50:51
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50:51Similar but different is a good way to describe how FDA inspections and MDSAP and notified body audits compare. On the surface, they appear to be looking at the same things, but dig a little deeper and the differences in agenda - and outcome - become plain.Michelle Lott által
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1
Usability Testing and the FDA
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32:35Do 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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RAQA Today
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1
Is your State of Affairs for MDR State of the Art?
1:03:11
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1:03:11If you're struggling to determine whether your devices qualify as state of the art - and how that can impact your submission strategy - then check out this presentation I did with my friends at Greenlight Guru in August.Etienne Nichols and I sort through all the acronyms - SOTA, SOC, MDR, MEDDEV, IVDR - and try to shed some light on what MDR says a…
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RAQA Today
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1
MDR, FDA and Other Regulatory Realities
35:41
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35:41When submitting a medical device for regulatory approval, it's always better to just dive in, accepting the fact that it's going to take a lot of work and require a lot of patience before you feel the glow of market clearance or approval.There are just SO MANY things to consider, and remember, and document, and SO MANY regulations to refer to on bo…
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1
Digital Health: The Future of Medicine and Medical Devices
43:14
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43:14Digital health technologies are exactly new, but they did get a huge boost from COVID and will define how we deliver healthcare in the future. Digital health includes telemedicine, software functions that allow providers to monitor patients remotely, apps that track medication use and provide user-configured reminders for improved compliance - and …
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The End of the COVID-Era EUAs
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42:09The end of the COVID-era emergency use authorization (EUA) is rapidly approaching - do you know what's next?Earlier in the year, the FDA laid out their proposed plans for transitioning devices marketed under and EUA or FDA enforcement policy - then went radio silent.They still haven't released their final guidance, so what's a manufacturer to do?In…
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1
Crash Course in FDA Submissions
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25:10So - you have a product, and you have a submission ready to go to the FDA. You're all set, right? You know how the e-Submitter works, you know exactly what FDA Form 3514 is for, and you know the best questions to ask the FDA during your pre-sub?If you've answered NO to any of these, then listen in as Michelle explains what you need to do to help yo…
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RAQA Today
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1
Five Steps to Bring a Medical Device to Market
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29:22So - you're a hot new startup with a snappy new medical device. Now what? Do you have an intended use statement? Do you have the 𝘳𝘪𝘨𝘩𝘵 intended use statement? Do you know for sure that your product qualifies as a medical device? What about your predicate device?There are a lot of potholes along the road to market clearance or approval, so come alon…
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RAQA Today
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Design Controls and Risk Management
1:19:43
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1:19:43Which comes first - design controls or risk management? Both - because the two are inextricably linked. In this podcast, we'll take an in-depth look at both design controls and risk management, the waterfall design process, how/where risk management fits into that process - and vice versa - as well as discuss the ISO and 21 CFR 820 requirements for…
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RAQA Today
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Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices
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47:59You've developed a novel technology and want to bring it to market in the US. Now what? Can you submit as a breakthrough device, or is the de novo route a better choice? How are they different? How are they similar? Breathe - and listen in as Michelle walks you through the options.Michelle Lott által
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1
The Aftermath Of MDR - Part III
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20:32In this final segment from 𝗧𝗵𝗲 𝗔𝗳𝘁𝗲𝗿𝗺𝗮𝘁𝗵 𝗼𝗳 𝗠𝗗𝗥 webinar, we discuss what you should and should not do when preparing for your certification, then segue into what you need to consider when building the business case for (or against) pursuing certification.This one runs a bit longer than 15 minutes because it includes most of the Q+A session, and tha…
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The Aftermath of MDR - Part II
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15:23Six months into MDR and manufacturers and notified bodies are clashing over differences in opinion and fighting over their respective interpretation of the standards in pursuit of product certification.In this second installment of a series, I share three real-world examples of what actual clients faced when going through the MDR certification proc…
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The Aftermath of MDR - Part I
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15:40It's no longer a secret that MDR has morphed into an unmitigated disaster for the medical device industry - and Michelle has the goods to prove it. In this first in a series, she spills the beans on notified body readiness, the roadblocks that have been causing the most trouble, and the FDA's long-term plan to become the easier pathway to market.…
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EUDAMED, MDR and Even More Madness with Richard Houlihan
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20:04This is the second part of my conversation with Richard Houlihan, where we delve into the current status of the EUDAMED database, the intricacies of the data entry process, and why the EU competent authorities are not your friends.Michelle Lott által
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EUDAMED, MDR and Other Madness with Richard Houlihan - Part I
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16:33We all knew that MDR would change the medical device industry forever, hopefully for the better. But as manufacturers grapple with redundant requirements and notified bodies struggle to attract and retain the qualified staff mandated by the new regulation, it becomes clear that MDR is not just changing the medical device industry - it's requiring a…
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The MDR No Good Very Bad Day: Go To Market Challenges in the EU
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12:14It used to be that Europe was the first choice when bringing a product to market. Relaxed regulation meant a quick approval and the chance to earn some money while waiting for FDA approval. That's not the case anymore, and thanks to MDR, there are new challenges and roadblocks - not to mention a LOT more expense - involved in bringing a medical dev…
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RAQA Today
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The FDA No Good Very Bad Day: Common Regulatory Mistakes
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14:51Whether you are an investor or inventor/founder, there are some things you need to avoid if you want your FDA submission to succeed, some common regulatory mistakes that a lot of startups make. These common misconceptions about the FDA submission process can cost you time and money and extend your go-to-market timeline, so it's worth knowing how to…
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1
Empowering Female Entrepreneurs and Investors with Faz Bashi
27:48
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27:48More and more women are investing in medtech startups as the next phase of their professional development. It's a key career move that can fuel further business growth while establishing women entrepreneurs as experts and investors to be taken seriously.But all investors need to know what to look for when gauging a pitch from a startup, because it'…
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How A Strong Regulatory Strategy Can Boost Your Business with Stephanie Schull
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19:56Does regulatory strategy really impact your business strategy? Yes! Stephanie Schull, founder of kegelbell, explains how defining the regulatory strategy for her fledgling business early on helped promote her product both to investors and distributors around the globe.Michelle Lott által
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FDA Submission Pathways with EIT Health Alumni
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32:35Determining which FDA submission pathway best applies to your medical device or product can be daunting. Listen in as Michelle explains how to decide if your product qualifies for a 510(k), PMA, de novo or 510(k) exempt submission - as well as the basic requirements for each.Michelle Lott által
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All You Ever Wanted to Know About Risk Management with Edwin Bills
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44:02No matter the risk management question, Edwin Bills will likely have the answer. He's been involved in the medical device quality and regulatory space for many, many years. Give him a tricky compliance situation or example, and chances are he has been there and done that, maybe more than once.Ed sat down with Michelle to talk about ISO 24971, MDR a…
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RAQA Today
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Regulatory and Reimbursement - Similar but Different
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39:16Are regulatory and reimbursement at all related? Does one influence the other? Or are they more like oil and water, both necessary but not really something you should mix?Michelle and Nic Anderson answer questions about how regulatory and reimbursement issues can impact a product's go-to-market strategy, and how these two seemingly disparate areas …
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FDA Device Downclassification - This is Not Good News
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26:54The recent FDA device downclassification decision is not good news - for industry or for patients. Several devices on this list - namely ventilators - have benefitted from close FDA scrutiny during the 510(k) submission process. They are safe precisely because they have been so closely regulated, not because they are simple to use and present limit…
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Robert has years of experience working for notified bodies, and provides a peek behind the curtain at the North American division of Norway's DNV GL Presafe. Hear what they have going on now, what may be coming up in the future, and how a notified body determines how to best manage a client project.Note: You didn't miss anything, and your headset d…
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RAQA Today
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Entrepreneurial Roundtable with Elena Kyria
17:15
17:15
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17:15In this clip from Elemed's Entrepreneurial Roundtable series, Michelle sits down with Monir El Azzouzi, Stefan Boelleininger and Elena Kyria to talk about the benefits and challenges of running your own business.You can hear the entire discussion at http://www.elemed.eu/mentoringMichelle Lott által
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RAQA Today
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Ventilators, Components and Accessories - Choosing the Right FDA Pathway for Your Product
26:08
26:08
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26:08Have you ever struggled to understand the regulatory difference between a product, an accessory and a component?Have you ever driven yourself slightly mad trying to determine the best FDA submission pathway for that product, accessory or component?A group of medical device manufacturers asked those very same questions during a presentation I gave i…
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RAQA Today
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PPE, Masks and FDA Regulations in the Age of Coronavirus
12:51
12:51
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12:51Protective gear is still in high demand, and absolutely everyone is making masks. In this April 2020 clip from Joe Hage’s weekly COVID-19 call, 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.…
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RAQA Today
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Regulatory Requirements and the "Simple" Surgical Mask
11:27
11:27
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11:27You have a raw material supplier. You have a marketing strategy. You have a sales funnel. But what you don't have is a clear understanding of the regulatory requirements for this new surgical mask you're making.Now what? Do you even know where to start?Michelle sits down with a client facing this dilemma and walks her through the regulatory process…
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RAQA Today
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RAQA Today Becomes leanRAQA Today: What's Next?
26:54
26:54
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26:54Mitch Robbins is moving on, and Michelle Lott of lean RAQA will be taking over the podcast! Mitch and Michelle chat about transitioning the podcast, what's ahead for the Anthony Michael Group, and what the leanRAQA team has in store for 2021.Michelle Lott által
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