#412: How to Build a QMS That Actually W...

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.

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

• 00:02 – Introduction to Greenlight Guru and medtech process integration
• 01:15 – QMS evolution from startup to commercialization
• 03:00 – Phase-based product development overview (Phases 0–6)
• 06:35 – Why QMS should follow product needs, not just regulatory triggers
• 09:10 – Agile vs. proceduralism in quality systems
• 11:50 – Building a quality culture during the feasibility phase
• 15:25 – When to implement QMS controls and how to prepare for “enforcement points”
• 18:40 – Investor-driven and regulatory QMS triggers
• 21:10 – How early QMS planning saves time and reduces future remediation
• 26:20 – Ashkon’s final advice for startups: start small and stay proactive

Standout Quotes

"You’ve got to take the BS—being burdensome—out of QMS."

Ashkon Rasooli redefines QMS as a project management tool, challenging the notion that compliance must be a burden. This quote encapsulates his philosophy of proactive, phased implementation that actually enhances product development.

"Start small and do a little bit at a time—it won’t seem like a burden."

A practical mantra for startups, this advice underscores how a gradual, well-aligned QMS rollout can prevent last-minute fire drills and wasted effort.

Top Takeaways

1. Use the "Phase 0–6" Model to Guide QMS Rollout – Align QMS implementation with the stages of product development to ensure each step supports the next.
2. Don’t Wait for Enforcement Points – Start building your QMS before regulators or investors demand it to avoid remediation-heavy implementations.
3. Prioritize Culture Before Controls – In early feasibility, focus on aligning your team with medtech’s safety responsibilities, rather than formal procedures.
4. Procedures Should Support Outcomes, Not Just Check Boxes – Avoid proceduralism by tying every process back to its intended quality objective.
5. Regulatory Strategy = Investor Strategy – QMS maturity is increasingly scrutinized during due diligence. Treat it as a value driver, not just a cost.

References

• Ashkon Rasooli on LinkedIn
• Greenlight Guru – Quality management software for medical devices
• Etienne Nichols on LinkedIn – Connect with the host
• ISO 13485 vs. ISO 9001 – Explains how medical device quality systems build on general standards
• ISO 14155 Overview – Relevant for clinical validation procedures

MedTech 101: What Are “Enforcement Points”?

In the context of QMS, enforcement points are moments when external stakeholders (regulators or investors) require proof of formalized processes. Think of it like a driver’s license checkpoint—you may be cruising just fine, but at that moment, you must prove you’re compliant. The earlier you prep for them, the smoother your...