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).

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.

Key Timestamps:

• 00:02 – Intro to Greenlight Guru and Episode Topic
• 03:30 – Introducing Ashkon Rasooli and his background
• 05:15 – Defining the “Non-BS QMS” approach
• 06:45 – Principle #1: Quality Over Proceduralism
• 12:00 – Navigating deviations in QMS and avoiding extremes
• 14:45 – Principle #2: Culture Over Mandate
• 22:10 – Principle #3: Redundancy Over Duplication
• 29:30 – Principle #4: Conciseness Over Verbosity
• 37:00 – The Importance of Designing for Regulatory and Quality from the Start
• 46:30 – Tactical QMS advice for new medtech founders
• 57:00 – Wrapping Up and Key Takeaways

Standout Quotes:

1. "There is a cost to quality. But quality done right can also be an enormous value-add, not just a regulatory checkbox." – Ashkon Rasooli
2. "A QMS should serve quality and compliance, but it has to be intuitive for every person in your company. Complexity does not mean quality." – Ashkon Rasooli

3 Key Takeaways:

1. Quality Over Proceduralism: Focus on the intent and impact of QMS processes rather than rigid adherence to procedures that may not reflect the realities of your business.
2. Culture Over Mandate: Building a culture of quality involves engaging every employee, not just those in quality roles, to ensure shared responsibility and proactive efforts.
3. Design for Quality Early On: Engaging with quality and regulatory advisors at the architecture and design phase can prevent costly rework and optimize compliance pathways.

References:

• Ashkon Rasooli on LinkedIn
• Etienne Nichols’ LinkedIn
• Greenlight Guru’s QMS Software: www.greenlight.guru

MedTech 101:

QMS (Quality Management System) – A structured system of procedures and processes covering all aspects of design, development, manufacturing, and distribution to ensure product safety, effectiveness, and regulatory compliance. Essential for medtech companies seeking to market devices in most global markets.

Audience Engagement:

Poll Question: "Does your company treat quality as a compliance necessity or a business differentiator? Share your thoughts!"

Feedback:

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