FDA | Quality & Regulatory

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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Written by Mark Swanson, Partner On April 3rd, the FDA issued the draft guidance titled, “Marketing Submission Recommendations for a...

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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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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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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...

Jackie Torfin

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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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...