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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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 [...]
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 Houliha [...]
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 medi [...]
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 Conferenc [...]
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: [...]
Validation of a regulated computer system – what’s the big deal?
Anyone who has been part of a successful validation effort for a regulated computer system (IT system) should consider t [...]
