Shows
Let's Talk Risk! with Dr. Naveen AgarwalLTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSRSummary“Delaying a product that is adequately safe and effective is itself a risk, one we rarely acknowledge in our quality systems.”In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal speaks with Ashkon Rasooli, a seasoned SaMD and AI/ML quality strategist, about what QMSR readiness really means for software-heavy medical device organizations.Ashkon explains why traditional hardware-centric quality thinking breaks down in software environments, where failures are deterministic, complexity is effectively infinite, and rapid iteration is the norm. He challenges the industry’s fixation on “bug-free” software and over-proce...
2026-01-3027 min
Global Medical Device Podcast powered by Greenlight Guru#443: Generative AI in MedTech: Quality, Risks, and the Autonomy Scale with Ashkon RasooliIn this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD). The conversation previews their upcoming session at MD&M West, focusing on the critical intersection of generative AI (GenAI) and quality assurance. While many AI applications exist in MedTech, GenAI presents unique challenges because it creates new data—text, code, or images—rather than simply classifying existing information.Ashkon breaks down the specific failure modes unique to generative models, most notably "hallucinations." He explains how these outputs can appear legitimate while being fact...
2026-01-2644 minGlobal Medical Device Podcast powered by Greenlight Guru#441: ICYMI (In Case You Missed It!) How Artificial Intelligence is Impacting the MedTech IndustryIn this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare. The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends."Validation of AI tools in MedTech requires a staged adoption to build confidence due to the inherent uncertainty in AI outcomes." - Ashkon Rasooli00:00 - Introduction to AI in...
2026-01-1245 min
The Hardtech PodcastBeyond Compliance: Quality Systems in MedTechHow 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...
2025-09-0138 min
The Med Device Cyber PodcastWhy Cybersecurity and Quality Are One and the SameHow can medical device startups avoid missteps in cybersecurity, quality, and compliance? In this episode, Trevor Slattery speaks with Ashkon Rasooli about the intersection of quality systems and cybersecurity in medical devices. They unpack why treating cybersecurity as a bolt-on checklist is ineffective and even dangerous. They also discuss regulatory realities, risk management frameworks, and how early-stage teams can avoid costly pitfalls by planning smarter from the start.Ashkon Rasooli is the CEO of EnGenius Solutions, a boutique consulting firm focused on medical device software development. With a background in both hands-on coding and compliance...
2025-07-0137 minGlobal Medical Device Podcast powered by Greenlight Guru#412: How to Build a QMS That Actually Works: From Startup to Scale in MedTechIn this live episode from the LSI conference in California, Etienne Nichols is joined by Ashkon Rasooli to break down what it really takes to build a high-performing quality management system (QMS) in medtech—from startup chaos to post-market scale. Ashkon shares a phased approach to aligning QMS implementation with product development, explains the concept of "enforcement points," and reveals how founders can reduce the burden of compliance by starting small and planning ahead. If you're navigating regulatory requirements while trying to stay innovative, this episode is your roadmap to smarter, leaner quality.Key Timestamps
2025-06-2316 minGlobal Medical Device Podcast powered by Greenlight Guru#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon RasooliIn this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by quality and regulatory expert Ashkon Rasooli to explore the essentials of creating a high-impact, non-burdensome Quality Management System (QMS). Ashkon shares his four guiding principles for building an effective QMS—emphasizing quality over proceduralism, culture over mandate, redundancy over duplication, and conciseness over verbosity. This conversation dives into strategies for optimizing QMS implementation, reducing overhead, and integrating quality culture company-wide. The episode wraps with tactical advice for new medical device founders on setting up their QMS for long-term success.
2024-11-0737 minGlobal Medical Device Podcast powered by Greenlight Guru#353: How Artificial Intelligence is Impacting the MedTech IndustryIn this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare. The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends."Validation of AI tools in MedTech requires a staged adoption to build confidence due to the inherent uncertainty in AI outcomes." - Ashkon Rasooli00:00 - Introduction to AI in...
2024-01-3045 min