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
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...
jackietorfin
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...
jackietorfin
Quality Management System Implementation is SO EASY....
Why implementing a QMS is NOT as easy as we're told...
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