Beyond Compliance: Quality Systems in MedTech

How do you build medical devices that are both innovative and compliant without drowning in paperwork? In this episode of The Hardtech Podcast, hosts DeAndre Harakas and Grant Chapman talk with Ashkon Rasooli, founder and CEO of EnGenius Solutions, about rethinking quality management systems in medtech. Ashkon shares his perspective on the No BS QMS manifesto, why redundancy is good but duplication is waste, and the challenges of validating AI-driven devices in regulated environments. They also discuss how the FDA is preparing new frameworks for AI, why a strong culture of quality beats check-the-box compliance, and how avoiding technical debt can accelerate real innovation. If you’re building in hardware, health tech, or regulated markets, this episode gives you a practical playbook for making quality systems work for innovation not against it. Special Guest: Ashkon Rasooli .