How to Build a Quality System That Doesn't Suck | Device & Conquer | S2:E5

About this episode

This episode discusses how to build an effective quality management system in MedTech that enhances compliance without overwhelming teams.

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 build a quality management system (QMS) that doesn’t suck —or suck the life out of your MedTech team. From the shift to FDA’s new QMSR aligned with ISO 13485:2016 to risk-based thinking, supplier controls, and right-sizing your documentation, this episode gives you actionable, real-world strategies to streamline your QMS without sacrificing compliance. Whether you’re a three-person startup or a 20,000-person organization, you’ll learn how to avoid bloated SOPs, empower teams to own their processes, and build a culture where quality is a partner—not the “business prevention department.” Includes horror-story “QMS Confessions” you won’t believe. Be sure to like and subscribe for even more insights on medical device regulations, compliance, and quality systems (it will be fun and not painful, we promise). Watch the video on YouTube: https://youtu.be/b947AW_N3nc Visit us at https://leanraqa.com/ for evenmore regulatory goodness and to learn more about our services. 📩Got a question or a topic for a future session? Drop it in the comments below…

People in this episode

Host: Michelle Lott

Guest: Ti

Topics covered

• Quality Management System
• MedTech
• FDA Regulations
• ISO Standards
• Risk-Based Thinking
• Supplier Controls
• Documentation

Keywords

• Quality Management System
• FDA
• ISO 13485:2016
• MedTech
• Compliance
• Risk-Based Thinking
• Supplier Controls
• Documentation
• SOPs
• QMS Confessions

Mentioned in this episode

Organizations: FDA, ISO 13485:2016, LeanRAQA

Places: MedTech

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