Quality Management System Implementation is SO EASY....
Why implementing a QMS is NOT as easy as we're told...
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Jackie Torfin
- Jun 15, 2022
- 3 min
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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jackietorfin
- May 2, 2022
- 2 min
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...
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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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