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jackietorfin
Apr 21, 20232 min read
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Written by Mark Swanson, Partner On April 3rd, the FDA issued the draft guidance titled, “Marketing Submission Recommendations for a...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, 20234 min read
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, 20232 min read
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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