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Life Sciences
TEDOR Pharma selects AssurX Quality Management Software to Automate and Streamline Processes
TEDOR expects to gain operational efficiencies for future growth using the AssurX platform Morgan Hill, CA., June 19, 20 [...]
FDA to Sunset Alternative Summary Reporting (ASR) Program
The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and wil [...]
Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest
FDA regulation 21 part 822 lays out the process, the rules, and the products that require postmarket surveillance. The [...]
Visit AssurX at the ASQ World Conference on Quality & Improvement [Booth 406]
AssurX, a leader in quality management software systems, will be exhibiting at the ASQ World Conference on Quality and I [...]
AssurX Names Stephanie McArdle as Vice President of Product Management for Life Sciences Industry
Morgan Hill, CA., May 16, 2019 -- AssurX, Inc. (AssurX), a leader in quality management and regulatory compliance softwa [...]
What to Make of FDA’s Secret Cache of Device Adverse Events
Last week an investigative report revealed the FDA has millions of “hidden” serious injury and malfunctions reports on m [...]







