Software as a service (SAAS) services featuring software for use by medical device manufacturers and regulatory professionals to manage post-market surveillance, complaint handling, adverse event tracking, signal detection, field safety corrective actions, and regulatory reporting under international compliance standards including FDA and EU MDR/IVDR; Software as a service (SAAS) services featuring software for cloud-based applications for use by medical device manufacturers, in vitro diagnostic (IVD) companies, and regulatory consultants to manage post-market surveillance and compliance activities; the software includes AI-powered natural language processing for complaint classification, predictive analytics for detecting emerging safety signals, and rules-based automation to support regulatory reporting workflows under international compliance standards including FDA and EU MDR/IVDR
Computer and Scientific