RAQA Today

In the Season 1 finale, Michelle and Ti challenge the traditional view of regulatory affairs as the “business prevention department.” Instead, they reframe regulators as strategic partners and proactive innovators who can drive compliance and competitive advantage.From shocking stories of last-minute compliance scrambles to major recalls that reshaped the industry, this episode reveals why being a “regulatory rebel” means understanding intent over letter, pushing back when it matters, and building trust across teams.Key takeaways:How proactive vs. reactive compliance impacts company culture and patient safetyWhy draft guidance matters (and how to use it to influence FDA thinking)The ethical and strategic case for regulatory professionals as innovatorsWhat Michelle and Ti would change if they ruled the FDA for a dayPerfect for regulatory pros, quality leaders, and anyone ready to challenge the status quo in medtech.Season 2 coming soon!

Everyone wants that shiny FDA Breakthrough Device designation — but what does it really take to earn it, and does it actually make a difference?In this episode, Michelle Lott joins Monir El Azzouzi on the Medical Device Made Easy podcast to unpack the truth behind the Breakthrough Devices Program — from eligibility and benefits to the myths, statistics, and reality checks every medtech company needs before applying.They discuss how this program — and its sibling, the Safer Technologies Program (STEP) — fits into the FDA’s pre-submission framework, the most common reasons applications are rejected, and why only a fraction of “breakthrough” devices ever make it to market.Here's what else you’ll learn:What the FDA Breakthrough Device Program is — and what it’s notKey differences between Breakthrough and Safer Technologies (STEP) programsHow to prove your device treats a life-threatening or permanently debilitating conditionWhy early data, prototypes, and patient advocacy are essential for successWhat the real benefits (and limits) of designation areHard stats: only ~12% of devices reach market authorizationHow to make your submission persuasive — and avoid the “rose-colored glasses” trapWhether you’re an early-stage startup or an experienced RAQA professional, this conversation demystifies one of FDA’s most talked-about programs — and shows you how to navigate it strategically.Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.Visit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

The EU Medical Device Regulation (MDR) has reshaped the European regulatory landscape — bringing new rigor, new challenges, and plenty of confusion.In this episode, Michelle Lott joins Etienne Nichols (Greenlight Guru) and Karandeep Singh Badwal to debate the real-world impact of MDR on medtech innovation, market access, and patient safety.From notified body bottlenecks to language barriers, inconsistent interpretations, and the myth of increased safety, the trio unpacks what MDR is really doing to the industry — and what manufacturers can do to survive (and thrive) under it.Here's what you’ll learn:How MDR differs from MDD — and why it’s not a total overhaulWhy software, AI, and post-market surveillance have become regulatory pain pointsThe 12–18 month reality of CE marking under MDRHow to select the right notified body (and why language matters)Why documentation ≠ device safety — and integrity still matters mostThe “significant change” rule: what triggers recertificationWhy smaller companies are struggling to stay in the EU marketPractical steps to build a quality culture and navigate MDR effectivelySubscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.Watch the video on YouTube: https://youtu.be/Kgbmh0neJpEVisit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

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

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

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 Instagram: https://www.instagram.com/leanraqa

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