AssurX Blog
Straight talk for regulated industries.
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 [...]
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 themselves lucky souls. Throughout my own personal development, t [...]
EU MDR Compliance: An Opportunity for Change
EU MDR Compliance: The new European device regulation will bring about impactful change. It is designed to do so. Since the 1990s, medical device regulation in Europe has been relative [...]
