Episodi
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In this episode Michelle and Adam Foresman from Ryden Solutions do a deep dive into right-sizing quality systems, lean regulatory practices, and the evolving landscape of AI-driven compliance tools in medtech. They reflect on personal pain points that sparked their ventures, swap audit war stories, and share insights into regulatory shifts like QMSR, MDR, and de-harmonization trends.
Highlights:
- The hidden costs of over-documentation and duplicated audits
- How AI can proactively identify compliance gaps — even across languages
- The future of audits: less paper, more floor time, and higher impact
- Why global harmonization is unraveling, and what that means for QA/RA teams
- Real examples of FDA using AI to detect duplicated or fraudulent data
This episode is a must-listen for quality, regulatory, and compliance leaders, especially those working in startups, scaling medtech companies, and global manufacturers navigating complex, multi-jurisdictional requirements. -
The FDA Breakthrough Device Program offers a expedited path to market for medical devices that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. It allows for prioritized review and enhanced communication with the FDA to help bring innovative devices to market more quickly, but it's not for everyone.
In this podcast, Michelle reviews the specifics of the program - the benefits, the requirements, the challenges - and talks about how you can decide if the program is right for you and your device.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
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Instagram: https://www.instagram.com/leanraqa -
Episodi mancanti?
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Did you know that 60% of startups cannot survive beyond five years, and 75% will ultimately fail?
These failures frequently stem from late regulatory involvement, underestimation of remaining development work, and the compounding effect of early oversights.
To mitigate these risks, a structured approach is essential, emphasizing early and continuous regulatory engagement, meticulous documentation through a trace matrix to ensure cross-functional alignment, and a well-defined regulatory strategy that aligns with the chosen FDA pathway. Prototyping and manufacturing must be carefully managed, considering the impact of material and process changes, and prioritizing design for manufacturability.
Finally, a strategic commercialization plan, including appropriate sales strategies, a clear understanding of the target market, robust intellectual property protection, and adequate funding, are crucial for navigating the complex medtech landscape and achieving sustainable success.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa -
Podcast of a July 2024 webinar event presented by Etienne Nichols and Greenlight Guru and featuring Karandeep Singh Badwal
The MDR is a comprehensive regulation that aims to improve patient safety and quality in the European Union, replacing the Medical Device Directive (MDD) and introducing more stringent requirements for manufacturers.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa -
Everything 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.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa -
Which 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 notified bodies.
27:15 - Nika Mendelev explains whether you really need to choose one or the other.
32:10 - the Q+A session begins.
Link to the full presentation on YouTube: https://youtu.be/4wyZzVibiAY -
Biocompatibility 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 conversation this month when I chatted with Mike McGrew and Sandi Schaible from WuXi AppTech.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
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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 States and Europe.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa -
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 effectively –the good, the bad, and the ugly.
The new features, including premarket approval content and updated cybersecurity documentation and dive into the simplified EMC questions, revised sterility section, and new biocompatibility testing options - we'll cover it all.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa -
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.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
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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. -
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 market, and why many companies are opting for fractional QA professionals rather than full-time employees.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa -
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.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa -
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.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa -
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!
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa -
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.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa -
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 implementation (spoiler alert: it ain't pretty).
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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 future might hold for both sides.
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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 all of the EU's problems, we did touch on some of the biggest challenges facing manufacturers. -
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 very heart of risk management, then this is the podcast for you. - Mostra di più
