QMSR & Agile: Navigating the Future of Software Quality
The transition to QMSR requires medical device companies to replace rigid, hardware-centric compliance with an agile, risk-based mindset that prioritizes rapid iteration and patient safety over bureaucratic perfection.
Generative AI in MedTech: Managing Risk in a Statistical World
TAs Generative AI shifts from classifying data to creating it, companies must pivot from traditional validation to a "Safety by Design" model that prioritizes real-time monitoring and human-in-the-loop autonomy. Success requires balancing the clinical benefits of AI with rigorous post-market surveillance to catch "hallucinations" before they impact patient safety.
Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli
In 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).
How to Build a QMS That Actually Works: From Startup to Scale in MedTech
In 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.
Why Cybersecurity and Quality Are One and the Same
Our founder, Ashkon R., joined the Med Device Cyber Podcast hosted by Blue Goat Cyber to unpack why quality systems and cybersecurity must be built hand-in-hand. From compliance frameworks to culture shifts, this episode explores what it really takes to launch a secure, compliant, life-saving product.
How AI is Shaping MedTech Cybersecurity
Ashkon Rasooli of Engenius Solutions joins Orthogonal’s Randy Horton and Ben Trombold to explore how AI is reshaping cybersecurity in medical devices.
The Hardtech Podcast | Beyond Compliance: Quality Systems in MedTech
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.
Is a Predetermined Change Control Plan (PCCP) Right For Your AI-Enabled Device?
This document does a high-level analysis of whether a PCCP would be a good addition to your regulatory strategy.
Fundamentals of AI in Health Care
In 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.