AssurX EU MDR Webinar Follow-Up: 10 FAQs for Tackling EU MDR Data Management
Last month, AssurX hosted a webinar entitled “Who Moved my MDR? Assessing Organi [...]
Validation of a regulated computer system – what’s the big deal?
Anyone who has been part of a successful validation effort for a regulated compu [...]
Visit AssurX at the ASQ World Conference on Quality & Improvement [Booth 406]
AssurX, a leader in quality management software systems, will be exhibiting at t [...]
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 man [...]
American Society for Quality (ASQ) CEO to Talk About Achieving a Culture of Quality at Upcoming User Conference
The same principles and tools that produce an effective military culture can be [...]
How Will Real-World Evidence Impact 2017 FDA Guidances?
The Advanced Medical Technology Association (AdvaMed) wants the Food and Drug A [...]
CDRH Report: Quality Management Insights For Medical Device Manufacturers
FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self [...]
FDA Warning Letters Emphasize Document Control System Compliance
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]
Cybersecurity Management Expectations Clarified By FDA
The FDA has made it abundantly clear that it expects medical device manufacturer [...]
Increased QMS Compliance Inspections For International Life Science Manufacturers
International QMS compliance inspections of pharmaceutical and medical device ma [...]
