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Latest Webinar!
"You implemented a CAPA, but did it actually solve the problem? Too often, organizations declare victory without verifying that corrective actions truly worked. That’s where Verification of Effectiveness (VOE) comes in. In this webinar, we’ll break down why VOE is the missing link in many CAPA systems, how to design meaningful effectiveness checks, and common pitfalls to avoid. Join us for a practical, no-nonsense discussion on making sure 'We fixed it' really means 'It’s fixed.'"
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​In this webinar, QRx Partners explore the significant business value of implementing a risk-based approach within the frameworks of ISO 9001 and ISO 13485. Attendees learn how effectively identifying, assessing, and managing risks throughout the QMS creates opportunities for continuous improvement and enhanced decision-making. Through real-world examples and practical insights, this session demonstrates how a proactive risk-based approach not only ensures compliance, but also drives operational efficiency, customer satisfaction, and long-term business success. This webinar is essential for quality professionals and business leaders looking to realize value beyond compliance from their QMS
Join QRx Partner Steve Gompertz as he presents "More Effective Root Cause Analysis: Next Level Strategies" in partnership with Intellect.
The agenda includes:
- Identifying the Problem: Can't find the cause(s) if you don't know what you're trying to address
- Investigation: Getting past the symptoms
- Analysis: Using your Quality toolbox to confirm the facts, the problem and the cause(s)
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Many managers and leaders love to talk about creating a culture of quality, but what does that actually mean? And why does it seem so elusive? Listen to Mark and Steve as they take a fresh look at quality leadership and show how to create an organization where quality is truly engrained.
Join QRx Partner Steve Gompertz during this webinar hosted by Intellect. He speaks about "Guerilla Tactics for Quality Leaders."
He talks about why you don't need to wait for permission to improve quality in your organization. You can create change by simplifying documentation, creating non-intimidating quality metrics, and making change stick, among other things.
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QRx Partner Steve Gompertz and Steve Fodem from Boston Scientific co-present at the 2024 SCOPE Summit.
​​Watch QRx Partner Steve Gompertz as he presents his "Risk Based Approach vs. Risk Management" program at a Medical Device Risk Management Conference.
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Join QRx Partner Steve Gompertz as he discusses Lean Documentation with Etienne Nichols, host of the ‪@GreenlightGuru‬ Global Medical Device Podcast - "Where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies."
Learn some excellent tips and tricks from QRx Partner, Steve Gompertz, on doing a great presentation and engaging your audience.
Learn more about Navigating FDA Approvals & the Regulatory Landscape with QRx Partner, Mark Swanson, in this short clip from a panel presentation and discussion with Go To Market Global, where Mark is a resident expert.
​(AUDIO ONLY) Join QRx Partner Steve Gompertz on the Being An Engineer Podcast hosted by Aaron Moncur as he discusses Medical Device Quality Control and Regulatory Requirements. He talks about the complexities of navigating the regulatory landscape in the medical device industry. He shares insights on the evolution of global regulations and the balance between innovation and quality control. He also provides strategies for developing effective quality management systems for companies of all sizes.​​
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When we consider folks who need to adhere to FDA regulations, we can't exclude people in marketing and even those in the realm of "influencer marketing." Join QRx Partners Steve Gompertz, Mark Swanson, and (former) QRx Partner Jackie Torfin as they discuss a specific FDA Warning Letter sent to Young Living Essential Oils with Chief Marketing and Product Officer Jason Voiovich.
QRx Partner, Steve Gompertz, presents to a room full at St. Cloud State University, Plymouth, MN campus on "Guerilla Tactics for Quality Leadership: Getting Things Done Without Formal Authority." Topics covered are:
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What are "Guerilla" Tactics?
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Common Quality Leadership Challenges
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Hide the Vegetables - Introducing new concepts without anyone realizing that they're learning them
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Measurement Without Fear - Measuring Processes Rather Than People
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More Effective Documentation - Applying Lean Thinking To Documentation
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The 7 Habits of Highly Effective Quality Leaders - Stephen Covey's Insights Applied to Quality Leadership
Video includes class interactions and Q & A.
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ISO, FDA, or any quality system audit can be about as nerve-wracking as going to the dentist. Worse, really, because so much is at stake. But what if you had a better sense of what your auditors might probe for and know just how far they will dig?
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Steve Gompertz, CMQ/OE, CMDA, RAC-US, CMII, shares his expert advice based on 30 years of experience on how to prepare for and conduct your next audit with total confidence. Expect practical insights — sprinkled with humor — to make your next audit less of a thriller and more of a smooth ride as he reveals what quality system auditors are really looking for.
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Take aways:
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Auditor objectives
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Effective audit preparation
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Do’s and don’t’s during an audit
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Insights into common audit pitfalls
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Strategies for engaging with auditors
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Tips for managing auditors’ expectations
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Preparation tactics beyond surface cleaning
Many consultants claim to be experts on the FDA's final rule for the Quality Management System Regulation (QMSR), which will replace the current QS Regulation in February 2026. However, very few have the experience of our consulting team since one of our Founding Partners, Mark Swanson, has been working directly with FDA personnel on both the comparison document (AAMI TIR 102) and ISO 13485:2016."
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Quality professionals often feel like no one understands them except for other quality professionals. The result is difficulty influencing the organization to adopt a culture of quality or act with urgency when needed. The cause may lie in differences in how people and organizations prefer to communicate. In 1992, Gary Chapman published “The Five Love Languages: How to Express Heartfelt Commitment to Your Mate”. It eventually landed on the NY Times Best Seller List for 4 years. The basic premise was that everyone communicates, as both the sender and receiver, in different ways. It’s natural to communicate to others in the way that we prefer to receive communication, but since others may have a different preference, your message may not be received as expected. Mr. Chapman described the five “love” languages as Acts of Service, Receiving Gifts, Quality Time, Words of Affirmation, and Physical Touch. This presentation applies Chapman’s ideas to Quality Leadership by proposing five equivalent quality communication or engagement approaches (Encouragement, Face Time, Mentorship, Collaboration, and Empathy), with a focus on first understanding which ones are your audience’s preferences, and how to “learn” that language. Understanding both of these preferences allows you to tailor your communications to what your audience needs or to recognize when the needed approach is not one of your strengths and warrants collaborating with someone else with that strength. The goal is to transform the Quality function from a hard-to-understand adversary to a trusted partner.
QRx Partner, Steve Gompertz, leads a round table discussion on "AI Tools for Risk Management" at the 2025 International conference on Medical Device Safety Risk Management in Amsterdam. Listen and learn with this insightful small group discussion.
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QRx Partner, Steve Gompertz, presents on "EU MDR-IVDR on Risk Reduction" at the 2025 International conference on Medical Device Safety Risk Management in Amsterdam.
Med device manufacturers, are you setting up your quality system early enough in product development? Also, are you misunderstanding the FDA’s "guidance" documents—and risking rejection? QRx Partners Mark Swanson and Steve Gompertz are passionate about helping med tech companies dodge the regulatory and quality pitfalls that derail so many startups. This episode explores how to classify your device properly, why cyber security documentation is required even for isolated software, and the evolving role of AI in medical technology.
