This episode features host Etienne Nichols and guest Andy Rogantino, who discuss the critical timing and process for evaluating and implementing an Electronic Quality Management System (EQMS).

They challenge the common "wait until something breaks" approach, emphasizing that the most effective MedTech teams integrate an EQMS early in the product lifecycle. The conversation covers the strategic and financial benefits of a well-implemented EQMS, the key stakeholders who should be involved in the evaluation process, and the core criteria for selecting the right software.

Rogantino highlights the importance of a purpose-built system and shares actionable advice on turning a quality system investment into a powerful tool for collaboration, efficiency, and audit readiness.

• 03:13 When is the right time to evaluate an EQMS?
• 04:27 How to prioritize an EQMS investment.
• 05:15 The three pillars of a MedTech company: financial, ethical, and legal/regulatory.
• 07:28 The dual benefits of an EQMS: reducing risk and increasing efficiency.
• 11:59 Who should be involved in the evaluation process?
• 17:32 What to look for when evaluating an EQMS.
• 23:13 The importance of a user-friendly interface.
• 26:53 Navigating the sales and demo process.
• 28:49 Defining clear success criteria for a QMS partnership.
• 31:45 What to avoid during the evaluation and purchasing process.
• 36:52 The compounding risk of doing nothing.
• 40:23 The importance of clinical data and its connection to the QMS.

• "When your house is already on fire, it's a little late to install some sprinklers." — Andy Rogantino.
• "If you're asking the question, 'should we build a QMS?', you probably should." — Etienne Nichols.

1. Prioritize Quality Early: Delaying an EQMS evaluation until a regulatory event or product issue occurs puts a company at a significant disadvantage. The most successful MedTech teams treat their QMS as the foundation of their business from the earliest stages of development.
2. Include All Stakeholders: An EQMS is not just for the quality department. Involve product development, regulatory, IT, and leadership. A system that breaks down silos and promotes collaboration across the entire organization is key to long-term success.
3. Invest for ROI: An EQMS is an investment, not an expense. It should be evaluated based on its potential to positively impact the financial bottom line by streamlining processes, reducing the risk of recalls or 483s, and accelerating time to market.
4. Seek a Purpose-Built Solution: Avoid generic, overly-customizable QMS platforms. A system built specifically for the MedTech industry, like Greenlight Guru, provides built-in guardrails and best practices that ensure compliance with standards like ISO 13485 and 21 CFR Part 820 from day one.
5. Evaluate for User Experience: The best software is simple and intuitive. During the evaluation process, consider how the system will feel for the people using it daily. A poor user interface can lead to low adoption and workarounds, negating the benefits of the investment.

• Cardiac Arrest: Five Years as a CEO on the Feds’ Hit List by Howard Root: A recommended read for MedTech leaders on the importance of robust quality systems and regulatory compliance.
• 21 CFR Part 820, ISO 13485, ISO 14971, and ISO 9001: Key regulatory and quality standards that an effective MedTech EQMS should be built to handle.
• Etienne Nichols’ LinkedIn: linkedin.com/in/etiennenichols
• Andy Rogantino’s LinkedIn: linkedin.com/in/andyrogantino

• EQMS (Electronic Quality Management System): An electronic system for managing quality processes and documents in a regulated industry. In MedTech, this software helps companies comply with standards like ISO 13485 and FDA regulations by managing design controls, risk, document control, and other quality-related activities.

Poll Question:

• When does your company typically start thinking about a QMS?
• A. Before development even begins.
• B. During the design and prototyping phase.
• C. When we're preparing for our first regulatory submission.
• D. When we receive a regulatory finding or warning letter.

Have thoughts on today's episode or want to suggest a future topic? We want to hear from you. Email us at [email protected]. Your feedback helps us deliver the most relevant and actionable content to the MedTech community.

• Greenlight Guru: The leading purpose-built Electronic Quality Management System (EQMS) for medical device companies. Greenlight Guru's platform is designed to help MedTech innovators bring safer, more effective products to market faster, ensuring compliance and efficiency from day one. To learn more, visit www.greenlight.guru.