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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 [...]
AssurX Receives HIPAA and HITECH Compliance Type 1 Attestation
Morgan Hill, CA – August 8, 2018 - AssurX,Inc. (AssurX), a leading provider of enterprise quality management and regulat [...]
