AI-POWERED POST-MARKET SURVEILLANCE FOR MEDTECH
Enterprise-grade post-market surveillance - built for teams of every size.
From complaint intake to adverse event reporting, recalls, risk management, and PMS reports, one connected workflow with AI embedded at every step. Whether you're a 20-person startup filing your first MDR or a global enterprise managing thousands, you get the same platform, the same AI, and the same compliance depth.
100% Salesforce-native
EU MDR Compliant
Trusted by 450+ MedTech companies of every size
From first complaint to final regulatory submission — one platform for every step in between.
Built for the outcomes your leadership actually cares about.
Submissions in minutes, not days
MDRs submitted to the FDA in 3 minutes through direct ESG NextGen API integration. No manual XML assembly. No last-minute deadline scrambles. The same submission workflow handles EU MIR and multi-market vigilance reports — one click, format-ready for each regulator.
AI that surfaces risk before it escalates
Smarteeva's AI continuously monitors complaint trends and adverse event patterns — flagging emerging safety signals before they become regulatory incidents or recalls.
Audit-ready from day on
Smart audit trails, meaningful data change tracking, and complete investigation documentation mean your PMS program is always ready for FDA inspections and Notified Body audits.
35%
of FDA MDRs. One Platform.
In the first 6 months: 95% reduction in duplicates from bulk imports.
70%
Faster complaint resolution
Median closure improved from 45–60 days to approximately 15 days
100%
FDA audit readiness
Audit evidence prep dropped from 24–48 hours to 30–45 minutes.
Purpose-Built
The regulated industries that depend on us.
Why smarteeva
What changes when your post-market workflow is purpose-built, not bolted on.
Other platforms
Built for document control across all industries. Post-market surveillance bolted on as an afterthought.
Complaint handling bolted onto a generic eQMS
Manual reportability decisions with no decision trees
Investigations, MDRs and complaints split across modules
IMDRF codes maintained manually, causing QC mismatches
Audit trails compiled manually across systems (24–48h prep)
AI add-ons with no guardrails, validation or audit trail
With Smarteeva
Built from day one for post-market surveillance. Every workflow, every AI model, every regulatory template designed for PMS.
Purpose-built complaint lifecycle in one guided flow
Built-in decision trees for MDR, MIR or both by jurisdiction
Complaints, investigations, and regulatory reports connected in real time
IMDRF codes sync bidirectionally between complaints and MDRs — eliminating manual updates and mismatches
Full audit trail on every record (prep cut to 30–45 min)
AI agents built with guardrails, logged actions, and escalation rules — fully auditable by design