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Have you ever wondered what it takes to get to the top of the Regulatory or Quality leadership food chain? Or, are you struggling with a specific piece of your business, and you are wonderin...
Most medtech teams underestimate the work before FDA submission—and overestimate what happens after clearance. In this episode, regulatory e...
A practical, lightly spicy guide to becoming the regulatory person teams actually respect—and want in the room. Learn how regulatory and qua...
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 bu...
If you’re thinking about investing in medtech, congratulate yourself—you’ve chosen one of the most exciting, innovative, and occasionally st...
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 Conq...
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 & Co...
The FDA pre-submission (Q-Sub) process can save you time — or sink your submission. In this episode of Device and Conquer , Michelle Lott an...
The FDA state of the union in 2025 - deregulation, QMSR, and a toilet paper shortage? Listen in as Michelle Lott and Tianna Benson tackle th...
Think you speak English? The FDA might disagree. In the Season 2 kickoff of Device &Conquer , hosts Michelle Lott and Tianna Benson break do...
In this episode, Michelle and guests take a deep dive into what’s really happening inside the FDA in 2025. From pre-submission strategies to...
In the Season 1 finale, Michelle and Ti challenge the traditional view of regulatory affairs as the “business prevention department.” Instea...
In this episode of Device and Conquer , we unpack the differences between the FDA’s inspection style and the EU’s notified body-driven appro...
Who really is the FDA and how do they regulate medical devices? In this episode of Device and Conquer , we break down the U.S. Food and Drug...
In this episode of the NEW Device and Conquer podcast, Michelle and co-host Ti dive deep into the European Union’s Medical Device Regulation...
What exactly is a medical device — and why does it matter if it’s regulated? In this premiere episode of Device and Conquer , hosts Michelle...
What if your quality system could audit itself — and tell you where you’re overcomplying, underperforming, or about to get caught in a regul...
Everyone wants that shiny FDA Breakthrough Device designation — but what does it really take to earn it, and does it actually make a differe...
Did you know that 60% of startups cannot survive beyond five years, and 75% will ultimately fail? Bringing a medical device to market is har...
The EU Medical Device Regulation (MDR) has reshaped the European regulatory landscape — bringing new rigor, new challenges, and plenty of co...
Everything you need to know about biocompatibility - in one podcast. From a webinar hosted by MedTech Leading Voice and featuring Michelle a...
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...
Biocompatibility testing is hot right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data...
The good folks at Vistatec invited me to participate in their Life Science In-Focus podcast last month, where host Karen Tkaczyk and I chatt...
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...
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 th...
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'...
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 necess...
As medical devices become more connected, concerns about security increase, leaving manufacturers - and regulatory staff - uncertain as to t...
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 S...
You may think document control is boring, but wait until you hear these stories: Red-lined post-it notes. Uncontrolled copies passed around...
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) a...
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...
Upload to EUDAMED is a requirement of MDR, but adoption has been slower than anticipated. Manufacturers are reluctant to invest in the time...
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...
Risk management can be difficult to understand, even for seasoned quality and regulatory professionals, because there are SO. MANY. ACRONYMS...
Orthopedic devices may qualify as medical devices, but they have very different regulatory requirements. So different that the FDA created a...
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 episod...
Similar but different is a good way to describe how FDA inspections and MDSAP and notified body audits compare. On the surface, they appear...
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 kno...
If you're struggling to determine whether your devices qualify as state of the art - and how that can impact your submission strategy - then...
When 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 l...
Digital health technologies are exactly new, but they did get a huge boost from COVID and will define how we deliver healthcare in the futur...
The end of the COVID-era emergency use authorization (EUA) is rapidly approaching - do you know what's next? Earlier in the year, the FDA la...
So - 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 kn...
So - 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...
Which comes first - design controls or risk management? Both - because the two are inextricably linked. In this podcast, we'll take an in-de...
You'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 d...
In this final segment from 𝗧𝗵𝗲 𝗔𝗳𝘁𝗲𝗿𝗺𝗮𝘁𝗵 𝗼𝗳 𝗠𝗗𝗥 webinar, we discuss what you should and should not do when preparing for yo...
Six months into MDR and manufacturers and notified bodies are clashing over differences in opinion and fighting over their respective interp...
It's no longer a secret that MDR has morphed into an unmitigated disaster for the medical device industry - and Michelle has the goods to pr...