Regulatory Compliance Management

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 for those [...]

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 and making [...]

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, this was [...]