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Written by Mark Swanson, Partner On April 3rd, the FDA issued the draft guidance titled, “Marketing Submission Recommendations for a...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
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
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, 20223 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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