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FOR QUALITY LEADERS

Your Team Is Too Talented to Spend Their Time on Data Entry

Smarteeva gives your quality team complete visibility into every complaint, adverse event, investigation, and quality trend, while AI handles the manual work that's consuming their capacity.

Trusted by 450+ MedTech companies of every size
The problem

Your tools are forcing skilled quality engineers, analysts, and investigators to spend 40% of their time on data entry, report assembly, and system administration. That's not a people problem. It's a tools problem.

The smarteeva alternative

The result isn't just a faster process. It's a fundamentally more capable quality operation.

AI handles what doesn't need humans
Intake, classification, triage, data extraction, report generation, trend detection, all automated so nothing waits on a manual step.
Your team focuses on what does
Root cause analysis, corrective action, regulatory strategy, and continuous improvement. The work that actually requires expertise.
Visibility across everything, in real time
Every complaint, every adverse event, every investigation, every quality trend, visible in one platform without building a report to find out.
Global compliance, one platform
FDA 21 CFR Part 803, EU MDR Vigilance, UK MHRA, Canada MDR, PMDA — Smarteeva handles multi-region regulatory reporting without multiple systems or manual format translations.
Scales with your portfolio
Whether you manage 10 device families or 200, Smarteeva handles growing complaint volumes and expanding regulatory obligations without adding headcount or custom configuration.
No consultant required
Purpose-built for PMS means it works out of the box. No months of configuration. No ongoing specialist dependency. Competitors require both — Smarteeva doesn't.

The capabilities quality leaders actually need

Real-Time Visibility Across Your Entire Quality Landscape

Smarteeva gives you a single dashboard view of every open complaint, every active investigation, every pending adverse event report, every CAPA, and every emerging trend across all products, all sites, and all regions. You don't need to run reports to see what's happening. You don't need to ask your team for status updates. The data is live, the metrics are current, and the picture is complete.

Walk into any management review or regulatory inspection with confidence, not with a stack of exported spreadsheets compiled the night before.

AI That Amplifies Your Team's Expertise

Smarteeva's AI doesn't replace your quality professionals. It removes the obstacles that prevent them from doing their best work. Complaints are pre-classified and risk-scored before your team sees them. Investigations start with AI-recommended root causes and similar case references. Adverse events are flagged automatically, with evidence. PMS reports are generated in minutes.

Your team's time shifts from processing data to analyzing data. From assembling reports to reviewing reports. From chasing compliance to driving quality.

Predictive Quality Intelligence

The most valuable quality insight isn't what happened last quarter. It's what's about to happen next quarter. Smarteeva's predictive analytics detect emerging complaint trends, identify anomalous patterns, and surface early indicators of potential systemic issues before they become audit findings, product actions, or patient safety events.

You stop reacting to quality problems and start anticipating them. Management reviews shift from backwards-looking summaries to forward-looking strategic discussions.

Scalability Without Proportional Headcount Growth

Complaint volumes grow with product portfolios and market expansion. With legacy systems, headcount grows proportionally. With Smarteeva, it doesn't. AI-powered automation means your team's capacity scales with the platform, not with hiring. You handle more products, more markets, and more complaints with the same team, at the same level of quality and compliance.

Measurable, Defensible Quality Metrics

Every action in Smarteeva generates data processing times, resolution rates, detection rates, triage accuracy, trend frequencies, and more. These aren't vanity metrics. They're the operational KPIs that demonstrate your team's effectiveness, justify your budget, and satisfy regulatory expectations for quality system monitoring.

The metrics that matter to you

Your Priority

Complaint resolution time
Team productivity
Adverse event detection
PMS report preparation
Audit readiness
Trend detection

Questions?

We’re glad you asked.

Is Smarteeva listed on the Salesforce AppExchange?

Yes. Smarteeva is certified on the Salesforce AppExchange, meeting Salesforce's security review and quality standards.

Can our Salesforce admin manage Smarteeva without specialized training?

Yes. Smarteeva is built using standard Salesforce platform tools. If your admin can configure Salesforce workflows, objects, reports, and page layouts, they can configure Smarteeva. Product-specific training is available but focuses on quality domain concepts, not technical platform skills.

Does Smarteeva work with Salesforce Service Cloud?

 Yes. Smarteeva integrates natively with Salesforce Service Cloud. Customer service cases that are identified as product complaints can be routed into Smarteeva's complaint management workflow automatically — no duplicate entry, no middleware.

What Salesforce editions does Smarteeva support?

Contact us for current Salesforce edition compatibility and licensing requirements.