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

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.
Don’t Wait for Enforcement Points – Start building your QMS before regulators or investors demand it to avoid remediation-heavy implementations.
Prioritize Culture Before Controls – In early feasibility, focus on aligning your team with medtech’s safety responsibilities, rather than formal procedures.
Procedures Should Support Outcomes, Not Just Check Boxes – Avoid proceduralism by tying every process back to its intended quality objective.
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...

#412: How to Build a QMS That Actually Works: From Startup to Scale in MedTech

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