Building a Better Market Pathway: Aligning Regulatory, Reimbursement and Commercialization Teams
Most medtech teams underestimate the work before FDA submission—and overestimate what happens after clearance. In this episode, regulatory e...
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RA/QA Today
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...
Episodes
20 of 66 episodes
How to be the Regulatory Person Everyone Actually Likes | Device & Conquer | S2:E6
A practical, lightly spicy guide to becoming the regulatory person teams actually respect—and want in the room. Learn how regulatory and qua...
How to Build a Quality System That Doesn't Suck | Device & Conquer | S2:E5
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...
Due Diligence for MedTech Investors: What You Really Need to Know Before Writing That Check
If you’re thinking about investing in medtech, congratulate yourself—you’ve chosen one of the most exciting, innovative, and occasionally st...
Why Picking a Predicate Can Make or Break Your 510(k) | Device & Conquer | S2:E4
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...
How to Build a 510(k) Without Losing Your Mind | Device & Conquer | S2:E3
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...
How to Submit a Pre-Sub (like a Pro) | Device & Conquer | S2:E2
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...
FDA Strategy 2025: Policy, Pressures and the Path to Medtech Clearance | Part I | leanRAQA Today | S5:E6
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...
How to Speak FDA (Without a Translator) | Device & Conquer | S2:E1
Think you speak English? The FDA might disagree. In the Season 2 kickoff of Device &Conquer , hosts Michelle Lott and Tianna Benson break do...
Inside the FDA: Pre-Subs, Wellness Devices & Cybersecurity Challenges | leanRAQA Today | S5:E5
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...
Rise of the Regulatory Rebel
In the Season 1 finale, Michelle and Ti challenge the traditional view of regulatory affairs as the “business prevention department.” Instea...
FDA 101: Audits, Classification Rules and EU MDR
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...
FDA 101: Understanding the OTHER Regulatory Giant
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...
EU MDR - More then Just Red Tape?
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...
Wait, What - There are Rules?!?!?
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...
QMSR, AI Reviewers and the Value of a Good FDA and Internal Audit | leanRAQA Today | S5:E4
What if your quality system could audit itself — and tell you where you’re overcomplying, underperforming, or about to get caught in a regul...
What You Need to Know About FDA Breakthrough Devices | leanRAQA Today | S5:E3
Everyone wants that shiny FDA Breakthrough Device designation — but what does it really take to earn it, and does it actually make a differe...
Medical Device Product Development: From Concept to Commercialization | leanRAQA Today | S5:E2
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...
EU Hot Takes: MDD vs MDR | leanRAQA Today | S5:E1
The EU Medical Device Regulation (MDR) has reshaped the European regulatory landscape — bringing new rigor, new challenges, and plenty of co...
Biocompatibility for MedTech Professionals
Everything you need to know about biocompatibility - in one podcast. From a webinar hosted by MedTech Leading Voice and featuring Michelle a...