AssurX Blog
Straight talk for regulated industries.
Patch Management Policy is Not an Option
How does a free software patch end up costing $700 million? When you don’t install it. The largest data breach in history is a hard lesson on the importance of having a patch managemen [...]
AssurX Announces Patch Management Software for Greater IT and OT Asset Cybersecurity Control
Process-based Patch Management solution turns awareness into action Morgan Hill, CA., July 9, 2019 – AssurX, Inc., a leader in enterprise quality management and regulatory compliance s [...]
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 [...]