AssurX Blog
Straight talk for regulated industries.
Top 10 Traits of World Quality Management Leaders
It’s World Quality Month (WQM) and that means taking time to reflect and recognize the impact that good quality management has on products and processes. What is good quality? We’ll l [...]
Have You Transitioned to Quality 4.0?
Quality 4.0 focuses on a collaborative approach to quality to ensure that quality is top of mind throughout an organization. The Quality 4.0 initiative is designed to expand the respon [...]
QMS Validation 101: SDLC vs. STLC Methodologies and Relationships
Validation is integral part of Good Manufacturing Practices (GMPs) and covers almost every aspect of manufacturing and processing activities. Quality Management System (QMS) software v [...]
Advanced Medical Solutions Selects AssurX Quality Management and Regulatory Compliance Software
AssurX Platform will Automate and Standardize Quality Operations in the UK, Netherlands, Germany and the Czech Republic MORGAN HILL, CA, UNITED STATES, October 22, 2019 -- AssurX, Inc. [...]
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 Organizational Readiness” with Richard Houlihan, CEO of Eudemed.eu and leading consultant and international sp [...]
FDA’s Fast Track Model for Software as a Medical Device (SaMD) Requires a Culture of Quality
Want to be part of FDA’s SaMD precertification program? Get your quality management system up to par. Software as a medical device (SaMD) is a growing sector in medical device technolo [...]
