# Smarteeva Orchestra: Your Team Builds the AI. No Code. No Data Scientists.

Orchestra is a visual drag-and-drop canvas where Quality and Regulatory teams design AI agent workflows tailored to their specific devices, regulations, and processes.

Trusted by 450+ MedTech companies of every size

## Complaint Intake & Classification

Complaints are captured, classified, and prioritized automatically, reducing hours of manual review and data entry.

### Stronger Safety Detection

AI analyzes every complaint narrative to identify potential adverse events and safety signals that could be missed in manual review.

### Accelerated Regulatory Work

Regulatory submissions and PMS reports are generated from real data in minutes instead of weeks of manual compilation.

## AI at Every Stage: From Intake to Submission

Smarteeva's AI is embedded across six critical stages of the post-market surveillance lifecycle. At each stage, AI handles the data-intensive work that slows humans down, while your team retains full control over every quality and regulatory decision.

1. **Intake**
    - **Complaint Intake & Classification**

Complaints arrive from email, phone, web forms, and bulk imports, each in a different format, each missing different fields. Smarteeva AI reads unstructured complaint text, extracts product, patient, event, and reporter details, and creates a structured record automatically. Missing fields trigger a targeted follow-up, not a generic email chain.

- **What most teams deal with**
        - Complaints are triaged by whoever opens them first. Severity assessed inconsistently across reviewers. Critical cases buried under routine volume. No standardized scoring; just individual judgment under time pressure.

- **How Smarteeva AI Solves It**  
        - AI analyzes each complaint against the MDR decision tree logic and assigns a Case Severity Score. Cases above the threshold are flagged for immediate escalation.

- **What Your Team Gets**  
        - High-risk complaints identified in seconds, not hours. Consistent prioritization across every reviewer.

2. **Triage**
    - **AI-Powered Triage & Prioritization**

Complaint queues often mix critical and routine issues, forcing manual triage. Smarteeva AI instantly classifies and prioritizes complaints so high-risk cases are escalated immediately.

- **What most teams deal with**  
        - Complaints with varying priorities lead to delays in addressing critical cases.

- **How Smarteeva AI Solves It**  
        - Automated decision trees assess severity and risk levels in real-time

- **What Your Team Gets**  
        - High-risk complaints surfaced immediately.

3. **Detection**
    - **Adverse Event Detection from Complaint Narratives**

Smarteeva AI scans every complaint to detect potential adverse events and flags them instantly for regulatory evaluation.

- **What most teams deal with**  
        - Adverse events can easily be missed through manual review.

- **How Smarteeva AI Solves It**  
        - The AI understands context, identifies clinical concepts, and recognizes patterns in language.

- **What Your Team Gets**  
        - A safety net that never overlooks a complaint.

4. **Investigation**
    - **AI-Assisted Investigation**

Smarteeva AI surfaces similar past cases, suggests investigation paths, and pre-populates records.

- **What most teams deal with**  
        - Investigators struggle with blank forms and manual data gathering.

- **How Smarteeva AI Solves It**  
        - AI analyzes complaint data to provide intelligent starting points.

- **What Your Team Gets**  
        - Investigations start with intelligence.

5. **Reporting**
    - **Automated Regulatory Reporting**

Smarteeva automatically generates draft submissions and surveillance reports from your data.

- **What most teams deal with**  
        - Preparing regulatory submissions is time-consuming.

- **How Smarteeva AI Solves It**  
        - Automatically maps complaint and adverse event data to the required fields.

- **What Your Team Gets**  
        - Regulatory submissions generated efficiently.

6. **Analytics**  
    - **Predictive Analytics & Signal Detection**

Smarteeva AI analyzes complaint data in real time to detect emerging patterns and potential safety signals early.

- **What most teams deal with**  
        - Quality trends are often discovered too late.

- **How Smarteeva AI Solves It**  
        - AI continuously monitors complaint volume and severity.

- **What Your Team Gets**  
        - A proactive quality management system.

## The Question Every Quality Leader Asks: "Can We Use AI and Stay Compliant?"

- **Human-in-the-Loop - Always**
    - AI recommendations are always reviewed and approved by your team.  
- **Full Audit Trail - Every AI Action Logged**
    - A complete audit record is generated for every AI-assisted action.  
- **Explainable AI - No Black Boxes**
    - Every AI classification comes with explanations.
    - 
- **Regulatory-Grade Security on Salesforce**
    - Runs on enterprise-grade infrastructure.
    - 
- **Built for Regulatory Workflows - Not Adapted for Them**
    - Designed around FDA and EU regulatory requirements.
    - 
- **Configurable Confidence Thresholds**
    - Your team controls AI recommendation thresholds according to needs.

## Performance Metrics

### Proof that AI-assisted compliance actually scales.

- **3.7×** More Explanations Generated
- **94%** Faster Understanding of Unfamiliar Code

Automating the complaint process improves efficiency and reduces manual data entry.

Smarteeva’s AI transforms your quality workflow, allowing your team to focus on making quality decisions instead of data entry.