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THE SMARTEEVA PLATFORM

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.

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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
Whats included

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.

Smarteeva Orchestra
Complaints Management
Adverse Events
PMS Reporting
Recall Management
MDREngine
MedTech Recalls Gateway
AI AGENT BUILDER — NO CODE

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.

AI-Powered

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.

Automated Detection & Reporting

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

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100+ Hours → 8 Minutes

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

End-to-End

Recall Management

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

FDA Data Intelligence

MDREngine

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

FOR MANUFACTURERS & HEALTH SYSTEMS

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
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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.

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Salesforce-Native

Not a bolt-on. Not middleware. Smarteeva is a 100% native Salesforce application that inherits the full security model, data architecture, and user experience of the Salesforce platform.

Cloud-Powered

Enterprise-grade compute, storage, and global availability from secure cloud infrastructure ensures your post-market surveillance data is always accessible, always fast, and always protected, regardless of where your teams are located or how quickly your data volumes grow.

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.

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.

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.
35% of FDA MDRs
More than a third of all Medical Device Reports submitted to the FDA are filed through Smarteeva. Direct ESG NextGen API submission.
70% Faster
Median complaint closure improved from 45–60 days to approximately 15 days.
1 in 5 FDA Recalls
One in every five FDA recalls is managed through Smarteeva 24–48 hours to 30–45 minutes.
FEATURES

Built for the Teams That Own Quality

For Quality Leaders

Visibility across every complaint, investigation, CAPA, and trend - in real time. Walk into management reviews and regulatory inspections with complete confidence, not a stack of spreadsheets.

For Regulatory Affairs

Automated MedWatch and MDR submissions, AI-generated PMS reports, and adverse event detection that catches what manual review misses. Spend your time on submission quality, not data assembly.

For Salesforce Administrators

Smarteeva runs natively on the platform you already manage. Configure workflows, fields, and automations using standard Salesforce tools - no new technology stack to learn.

For Executives & VP Quality

One platform replacing multiple legacy systems. Measurable ROI: faster complaint resolution, lower compliance risk, and a team that spends time on quality improvement instead of data entry.

See How AI Transforms Your Quality Workflow

Whether you're a 10-person startup or a global enterprise, this is the same platform. No tiers. No feature gates.

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Trusted by leading enterprise companies around the world
Trusted by 450+ MedTech companies of every size