What eQMS Vendors are Missing About the Process Approach
By Steve Gompertz, QRx Partner As a consulting firm we get courted frequently by eQMS vendors who hope we will introduce our clients to...
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letsdothis747
- Mar 20
- 2 min
Quality Beyond Compliance - Making Quality Part of Your Way of Life
By Mark Swanson, QRx Partner There has been some discussion around the amendment published in several of the ISO management system...
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letsdothis747
- Dec 21, 2023
- 2 min
Is the FDA Really Replacing the QS Reg??
By: Mark Swanson, QRx Partner As we wind down in 2023, many people still hope that the final rule for the US Quality Management System...
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letsdothis747
- Nov 28, 2023
- 5 min
Improving Compliance and Effectiveness Through Leaner Documentation
By Steve Gompertz, QRx Partner I recently talked about this subject at the Masters Summit 2023 in Salt Lake City. For anyone who couldn't...
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letsdothis747
- Sep 14, 2023
- 1 min
UPDATE: NEW FDA DRAFT GUIDANCES FOR 510(k) PRODUCTS
By: Mark Swanson, QRxPartner Planning to contact the FDA to get your product cleared?!? This process is often like looking through a...
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jackietorfin
- Jun 20, 2023
- 4 min
Things Deming and Others Never Said
by Steve Gompertz, QRx Partners We’re going in a different direction for this month’s blog article, by focusing on more of a “soft” skill...
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jackietorfin
- Apr 21, 2023
- 2 min
Get Ready for FDA Accepted Predetermined Change Control Plans!
Written by Mark Swanson, Partner On April 3rd, the FDA issued the draft guidance titled, “Marketing Submission Recommendations for a...
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jackietorfin
- Mar 23, 2023
- 4 min
Auditing, the Often-Thankless Task
by Steve Gompertz, QRx Partners Performing audits is great way to increase your understanding of quality management system requirements...
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jackietorfin
- Jan 25, 2023
- 2 min
The Long and Winding Road - Shortcuts to FDA Market Authorization
by Mark Swanson and Steve Gompertz, QRx Partners While most medical devices are required to follow the 510(k) and PMA pathways, the FDA...
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jackietorfin
- Dec 16, 2022
- 3 min
Likely EU MDR Postponement: EU Finally Sees the Light
by Steve Gompertz, QRx Partners If you’re involved in the medical device industry, you’ve likely heard recently that the EU is...
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jackietorfin
- Oct 24, 2022
- 1 min
Artificial Intelligence vs. Augmented Intelligence: Will the Real "AI" Stand Up?
By Mark Swanson, QRx Partners The latest ‘fad’ seems to be the push to apply artificial intelligence to medical devices and procedures....
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jackietorfin
- Sep 25, 2022
- 2 min
Training Effectiveness: It’s Not Actually About Measuring the Trainees
by Steve Gompertz, QRx Partners While presenting workshops recently, the topic of training effectiveness kept coming up. In both...
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jackietorfin
- Jul 14, 2022
- 1 min
Warning….no more extensions…we expect you to comply!! (MDCG 2022-11)
Written By: Mark Swanson, Partner Last month (June 2022) saw the Medical Device Coordination Group (MDCG) issue a short (only 2 pages)...
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Jackie Torfin
- Jun 15, 2022
- 3 min
Process Approach: The Missing Link to an Effective QMS
Written By: Steve Gompertz, Partner It’s pretty common for Quality Manuals to depict the Quality Management System (QMS) structure as a...
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jackietorfin
- May 2, 2022
- 2 min
Riding the wave of the new Quality Management System Regulation
Written By: Mark Swanson, Partner, CEO Having just returned from the MD&M West Conference in Anaheim, CA, it was interesting to hear what...
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Steve Gompertz
- Mar 15, 2022
- 3 min
Problem Definition: The Three Most Common Mistakes
Written by: Steve Gompertz, Partner, COO During a presentation the other day on steps for effective Root Cause Analysis (RCA), attendees...
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jackietorfin
- Feb 22, 2022
- 3 min
The Fallacy of the "Original Paper Record"...
Written by: Jackie Torfin, Partner, CCO It happens at least a few times a year as I interface with pharma/bio/med tech clients. We start...
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jackietorfin
- Jan 10, 2022
- 1 min
European Medical Device Certifications—Watch out…the bar is much higher than before!
By Mark Swanson Well, here we are fully engaged in the transition time for product certifications under the European Medical Device...
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stevegompertz
- Nov 7, 2021
- 3 min
Guerilla Tactics for Changing Quality Culture
Written by: Steve Gompertz, QRx Partners The term “guerilla tactics” likely conjures images of ragtag armed fighters skulking about the...
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jackietorfin
- Oct 25, 2021
- 2 min
Case Study - Laboratory Quality System Requirements Overload
Written By: Todd Debaker, Consultant for QRx The Problem Two laboratories owned by the same company, one a biocompatibility testing...
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