Beyond Compliance: How Ashkon Rasooli Is Rethinking Quality in MedTech

What if a quality management system could do more than satisfy regulators? For Ashkon Rasooli, that question has shaped a career focused on software, medical devices, and bringing modern technology into a highly regulated industry. As founder and principal of EnGenius Solutions Consulting, Ashkon helps companies build quality systems that support innovation without creating unnecessary burden.

From Medical Devices to Software-Focused Quality

Ashkon’s career spans major medical device companies, Silicon Valley startups, and Google’s Verily, with software serving as the common thread. He has worked across product management, engineering, testing, quality, and regulatory, gaining experience with Software as a Medical Device (SaMD) and software integrated into medical devices. After encountering similar challenges across organizations, Ashkon launched his consulting practice. He recognized that innovation was often slowed by quality processes not designed for today’s rapidly evolving software landscape. His goal became finding efficient ways to meet quality and regulatory requirements without creating unnecessary burden. As he explains, “How do you ensure quality in a least burdensome manner? It's a problem that requires a lot of creativity.”

Why Quality Systems Need to Evolve

Medical technology changes quickly, while quality and regulatory requirements must prioritize safety and risk. That creates a difficult balancing act as software development becomes increasingly agile, cloud-based, and AI-driven. Ashkon believes the industry faces a growing gap between modern technology and traditional approaches to quality. Regulators and industry organizations are working to address emerging technologies, but companies still must translate broad requirements into practical systems. For software companies, that translation can be especially challenging. Processes developed when software was distributed on physical media do not necessarily make sense for cloud-based products that are continuously updated. The challenge is not simply following regulations, but understanding their intent and applying it appropriately.

Quality Should Be a Business Strategy

One of Ashkon’s strongest arguments is that quality should not exist solely as a compliance function. Companies should consider quality alongside regulations, business strategy, and product technology. For early-stage companies, that means building systems that match their size, resources, technology, and immediate milestones while anticipating growth. What works for a small startup preparing for an FDA milestone may not work once the company scales and manages more design changes, complaints, and post-market activities. Ashkon warns that treating quality as a checklist creates burden without creating value. “The burden doesn't go away. You have to do it, but you get none of the value.” 

Three Questions Every QMS Should Answer

When Ashkon evaluates a quality management system, he looks beyond compliance and asks three essential questions: "Is it compliant? Does it actually improve quality? And is it efficient?" Compliance is the starting point, but it’s not the finish line. A strong QMS should help teams build reliable products, identify problems early, and prevent issues from becoming costly failures. It should also be practical, efficient, and aligned with how teams actually develop products. Achieving that balance requires collaboration. Quality professionals bring expertise in regulatory requirements and intent, while engineers and product teams understand the technology and development process. Bringing these perspectives together can create quality systems that do more than check a regulatory box. They can improve products, reduce risk, and support innovation.

Why This Matters

Ashkon’s perspective highlights a larger lesson for medtech companies: quality should not be viewed as a barrier to innovation. When thoughtfully designed, a quality system can reduce risk, improve efficiency, and support sustainable growth. Instead of asking only, “Are we compliant?” leaders should also ask: "Is our quality system helping us build better products, identify problems early, and create lasting value for patients?"

What to Watch

As software, AI, and medical devices continue to converge, quality systems must evolve with them. Ashkon’s approach offers a clear philosophy: quality should protect patients while enabling companies to innovate efficiently. Compliance and innovation don’t have to compete. A well-designed quality system can help teams move faster, make smarter decisions, and ultimately deliver safer, higher-quality products.

To learn more, listen to the full Project Medtech Podcast episode featuring Ashkon Rasooli, founder and CEO of EnGenius Solutions Consulting: https://www.projectmedtech.com/projectmedtechpodcast/episode/3f4c0860/episode-276-ashkon-rasooli-founder-ceo-of-engenius-solutions-llc-beyond-compliance-building-quality-systems-that-give-medtech-companies-an-edge