Smarteeva is a post-market surveillance platform built natively on Salesforce for medical device manufacturers. Most alternatives are quality management systems that add post-market surveillance as a module. The difference shows up in complaint intake, IMDRF coding, reportability decisions, and regulatory submissions, where Smarteeva runs the full chain on one data model instead of connecting separate tools.
Quality management systems were built to control documents, training records, and change processes. Post-market surveillance was added to them later, usually as a module that stores complaint records and routes approvals.
That works until the regulatory work starts. A complaint has to be coded, assessed for reportability against the rules of every market you sell in, and turned into a submission on a deadline. Those steps need a data model that understands device codes, event types, and reporting timelines.
Smarteeva starts there. Complaints, adverse events, risk assessments, and recalls share one data model, so a change in one updates the others without an export or a handoff.
