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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: [...]
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 [...]
AssurX Announces Patch Management Software for Greater IT and OT Asset Cybersecurity Control
Process-based Patch Management solution turns awareness into action Morgan Hill, CA., July 9, 2019 – AssurX, Inc., a lea [...]
EU MDR Rules Could Impact Medical Device Business Strategies
Changes in the European Union (EU) MDR and IVDR standards could force business change in the EU’s MedTech market. The se [...]
