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
- 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
- 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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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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jackietorfin
Auditing, the Often-Thankless Task
by Steve Gompertz, QRx Partners Performing audits is great way to increase your understanding of quality management system requirements...
jackietorfin
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...
jackietorfin
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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