Latest Webinar!
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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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.
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Watch QRx Partner Steve Gompertz as he presents his "Risk Based Approach vs. Risk Management" program at a Medical Device Risk Management Conference.
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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