AssurX Blog
Straight talk for regulated industries.
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 [...]
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 [...]
AssurX Demonstrating Regulatory & Quality Management Solutions at 2019 RAPS Conference
Next week, AssurX will be exhibiting at the annual Regulatory Affairs Professionals Society (RAPS) Convergence Conference 2019 in Philadelphia. RAPS is the largest global organization [...]
Cybersecurity for Medical Devices – Who’s Accountable?
Cybersecurity for Medical Devices is on the agenda for the U.S. Food and Drug Administration (FDA) September 10, 2019: Patient Engagement Advisory Committee. PEAC will be discussing [...]
