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Written by Mark Swanson, Partner On April 3rd, the FDA issued the draft guidance titled, “Marketing Submission Recommendations for a...
top of page
Search
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...
56 views0 comments
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...
33 views0 comments
Jackie Torfin
Jun 15, 20223 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...
132 views0 comments
jackietorfin
May 2, 20222 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...
53 views0 comments
bottom of page