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
- Oct 26
- 2 min
The Power of Strong Leadership in Quality Roles: Celebrating Women's Contributions
By: Jackie Torfin, QRx Partner In today's dynamic and ever-evolving business landscape, quality leadership is pivotal in ensuring an...
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letsdothis747
- Sep 14
- 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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letsdothis747
- Jul 21
- 3 min
How a GLP Facility Can Go Digital in a Compliant Manner
By Jackie Torfin, QRxPartner We recently completed a workshop on How a GLP facility can go digital in a compliant manner at a large...
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jackietorfin
- Jun 20
- 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
- May 18
- 4 min
From Meh to Magnificent! Using Situational Leadership to Improve Your Quality Culture
Written By Jackie Torfin, Partner Does this seem familiar? In a small company called Inept Inc., a well-intentioned but misguided manager...
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jackietorfin
- Apr 21
- 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Written by Mark Swanson, Partner On April 3rd, the FDA issued the draft guidance titled, “Marketing Submission Recommendations for a...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
- 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
- Feb 20
- 2 min
Change is Hard. Why Progressive Improvement BEATS Postponed Perfection.
Written by Jackie Torfin, Partner I "DO" change leadership. I am a proud change agent. I have led many change initiatives, from Quality...
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jackietorfin
- Jan 25
- 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
- Nov 17, 2022
- 3 min
Quality Management System Implementation is SO EASY....
Why implementing a QMS is NOT as easy as we're told...
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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
- Aug 4, 2022
- 2 min
How the FDA Warning Letter to Young Living Essential Oils should influence Influencer Marketing
Written by: Jackie Torfin, Partner A warning letter published on July 19th by the FDA to Young Living Essential Oils names not only the...
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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 24, 2022
- 3 min
The Value of a Quality Strategy
Written By: Jackie Torfin, Partner, CCO Every successful business has a reason for existence, a long term mission/vision and...
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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...
60 views0 comments
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