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...
The Long and Winding Road - Shortcuts to FDA Market Authorization
Likely EU MDR Postponement: EU Finally Sees the Light
Quality Management System Implementation is SO EASY....
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Warning….no more extensions…we expect you to comply!! (MDCG 2022-11)
Process Approach: The Missing Link to an Effective QMS
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Problem Definition: The Three Most Common Mistakes
The Fallacy of the "Original Paper Record"...
European Medical Device Certifications—Watch out…the bar is much higher than before!
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Case Study - Laboratory Quality System Requirements Overload
The Long and Winding Road - Shortcuts to FDA Market Authorization
Likely EU MDR Postponement: EU Finally Sees the Light
Quality Management System Implementation is SO EASY....