One Platform. Every Post-Market Workflow. AI Across Everything.

Smarteeva takes a fundamentally different approach. We built one unified platform where every product shares the same data model, the same AI engine, the same audit trail, and the same Salesforce.

Traditional Platforms

  • Separate systems for complaints and vigilance
  • Disconnected tools for PMS and recalls
  • Duplicate data entry across departments
  • Manual triage and investigation workflows
  • Fragmented product and complaint history
  • Slow signal detection and trend analysis
  • Heavy IT effort for integrations
  • Costly middleware to sync systems
  • Limited automation and AI support

With Smarteeva

  • One platform for complaints, vigilance, PMS
  • Field Corrective Action (FCA) management
  • Single source of truth for all product data
  • AI-assisted complaint triage and analysis
  • Complete product lifecycle traceability
  • Real-time signal detection and insights
  • Native Salesforce
  • No middleware or patchwork integrations
  • Continuous learning AI across workflows

Six Integrated Products. One Connected Ecosystem.

Start with one product. Add more when you're ready. Every product runs on the same data model and AI engine, so a complaint record created in Complaints Management is already connected to your Adverse Events, PMS, and Recall workflows. No migration. No reintegration. No "Phase 2" project.

Integrated Products:

Smarteeva Orchestra

The full complaint lifecycle in one guided workflow - from the moment a complaint arrives to the day it closes.

Email, manual entry, and bulk import all feed the same structured process. AI extracts fields from unstructured emails, flags potential duplicates using similarity logic (not just exact matches), and suggests IMDRF codes from the complaint narrative. Every record carries a full audit trail. Every investigation, MDR, and CAPA links back to the source complaint automatically.

Whether your team handles 50 complaints a month or 5,000, the workflow is the same. The AI is the same. The audit trail is the same.

Complaints Management

Next-generation complaint handling with AI-driven intake, automated risk assessment, machine learning-guided investigation, and customer self-service - compliant with FDA, EU MDR, PMDA, and TGA.

Adverse Events

AI-powered adverse event detection from complaint narratives, automated MedWatch and MDR report generation, and seamless tracking of MDRs, MIRs, CVRs, and PSURs, with smart audit trails and e-signatures.

Automated PMS Reporting

Fully automated post-market surveillance reports - EU PSUR, UK PSUR, EU PMSR, UK PMSR, PMPF-ER, and HCSR, generated in minutes by pulling directly from your complaint and quality data.

Recall Management

Fast notification generation, intelligent approval workflows, follow-up tracking, and a dedicated recall management portal for customers, affiliates, and distributors.

MDREngine

Aggregated, cleaned, and correlated regulatory data - MDRs, FAERs, recalls, warning letters, clinical studies, and industry news, in one searchable intelligence platform.

MedTech Recalls Gateway

A two-sided portal connecting medical device manufacturers with the hospitals and health systems affected by their recalls. Manufacturers issue recall notifications through one dashboard. Health systems receive alerts, acknowledge receipt with one click, and track required actions, no email chains, no lost PDFs, no manual follow-up spreadsheets.

AI That Runs Through Everything

Smarteeva's AI continuously monitors complaint trends and adverse event patterns, flagging emerging safety signals before they become regulatory incidents or recalls.

  • Fully auditable AI actions
  • Humans stay in control
  • AI built for regulated industries

Salesforce & Secure Cloud Infrastructure

Smarteeva runs natively on Salesforce and is powered by secure, globally distributed cloud infrastructure. Your data stays in the same environment as your CRM and Service Cloud, your team works in a familiar interface, and IT manages a single platform instead of multiple systems.

Enterprise-grade compute, storage, and global availability ensure your post-market surveillance data is always accessible, always fast, and always secure, wherever your teams operate. Together, Salesforce and cloud-native architecture give Smarteeva the security, compliance, and scalability that standalone quality management systems can't match.

Regulatory-Grade Security

Encryption at rest and in transit, role-based access controls, field-level security, granular user permissions, e-signatures, and a complete audit trail that meets the demands of FDA 21 CFR Part 11, EU MDR, and ISO 13485 inspection. The same security framework protects every customer.

Configurable, Not Coded

Fields, workflows, decision trees, reports, dashboards, and automation rules are all configured through the standard Salesforce platform. Your admin handles changes in clicks - no vendor engagement, no professional services, no ticket queue. This is how a three-person quality team stays as agile as a three-hundred-person one.

Features

  • For Quality Leaders: Visibility across every complaint, investigation, CAPA, and trend - in real time.
  • For Regulatory Affairs: Automated MedWatch and MDR submissions, AI-generated PMS reports, and adverse event detection.
  • For Salesforce Administrators: Configure workflows, fields, and automations using standard Salesforce tools.
  • For Executives & VP Quality: One platform replacing multiple legacy systems. Measurable ROI: faster complaint resolution, lower compliance risk.