AssurX Blog
Straight talk for regulated industries.
EU MDR Rules Could Impact Medical Device Business Strategies
Changes in the European Union (EU) MDR and IVDR standards could force business change in the EU’s MedTech market. The second-largest market for medical devices is about to go through a [...]
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, 2019 – AssurX, Inc., a leader in enterprise quality management sof [...]
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 will make the data publicly accessible. The ASR program originally [...]
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 process is an active, systematic, scientifically valid method of [...]
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 Improvement this weekend in Fort Worth, Texas. Starting Sunday, M [...]
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 software, today announced the appointment of Stephanie McArdle as Vice [...]
