Summary

“If you’re a small company and feel stuck in the QMSR transition, use that startup energy. Get creative, tap your network, and find the experts who can help you get unstuck.”

In this episode of the Let's Talk Risk Podcast, Megan Kane joins host Dr. Naveen Agarwal to unpack what the FDA’s new Quality Management System Regulation (QMSR) means for startups and small MedTech companies. She explains how the shift from checklist compliance to process-based assurance challenges teams to think differently - embedding risk management early, strengthening design controls, and elevating competence beyond routine training.

Drawing from her diverse experience across AI-enabled SaMD, diagnostics, and implantables, Megan shares how agile organizations can turn regulatory change into an advantage. She discusses building risk-based quality systems, tapping external expertise through fractional leadership, and fostering a culture of continuous learning where expertise grows with every project.

Chapters

00:00 Why QMSR matters now

02:00 Inside the startup mindset: energy, agility, and chaos

04:30 From checklists to connected processes

06:45 How FDA’s expectations are evolving

09:50 Integrating risk management with design controls

13:30 Competence vs. training: what QMSR really demands

15:30 Startups and global thinking: harmonization as opportunity

18:00 Leveraging networks and external expertise

22:00 Building courage and translating skills to new domains

24:00 Overcoming imposter syndrome and redefining expertise

26:30 Final takeaways and Megan’s vision for Relia

Suggested links:

* LTR: A 90-day plan to review QMSR readiness.

* LTR: Risk, CAPA and FDA inspections under QMSR.

* LTR: QMSR QuickTake #1: From compliance to assurance.

Key Takeaways

* The QMSR transition signals a shift from procedural compliance to process-based assurance.

* Startups have a unique advantage. Their speed and adaptability can drive faster QMSR readiness.

* The new regulation demands earlier integration of risk management into design and development.

* FDA reviewers are already expecting deeper risk-to-design traceability, even premarket.

* Competence, not just training, will define readiness under QMSR.

* Leadership must create cultures that encourage learning and vulnerability, not perfection.

* “Experts” aren’t the goal; continuous growth and shared learning are.

* For startups, external networks and fractional leadership can fill critical capability gaps.

* Global harmonization is coming; QMSR is the first step toward a unified framework.

* Success depends on collaboration across the quality community, not isolated effort.

Keywords

QMSR, ISO 13485, FDA, risk management, competence, startups, leadership, regulatory strategy, AI/ML, medical devices

About Megan Kane

Megan Kane is a fractional regulatory and quality executive with expertise spanning medical devices, digital health, and AI-enabled SaMD. As Founder and Executive Director of Rellia, she helps early-stage MedTech companies navigate global regulatory pathways and develop practical, risk-based quality systems. Her career spans startups, global corporations, and contract manufacturing, giving her a unique lens on how to simplify complex regulations into sustainable systems. Rellia is an incubator for digital health startups, helping the next generation of healthcare innovators.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe