How a digital health company built a Five-Team Complaint Management System with Automated FDA and Health Canada Submissions on Smarteeva
This customer builds FDA-cleared, CE-marked software that is regulated as a medical device. As a software-as-a-medical-device (SaMD) company operating across the US and Canada, they needed a post-market surveillance system that matched the complexity of their regulatory environment without requiring a large compliance team.
Because the product operates as a SaMD, every complaint, adverse event, and field report carries regulatory reporting obligations across the US (FDA) and Canada (Health Canada).
Five teams, one platform. Every regulatory submission auto-populates from product registration. Decision trees fire automatically. FDA submissions go through the NextGen API with acknowledgement tracking. Every change across every record is audit-trailed.
The Challenge
As the product matured and regulatory obligations grew, the team recognised the need for a purpose-built system. Quality, Regulatory, Customer Care, Product, and Risk teams each needed different access levels and different views of the same complaint data. The company was ready to move to a platform where role-based access, automated decision trees, and direct regulatory submissions could all operate inside a single connected workflow.
- Five teams needing different access levels and views of the same complaint data
- Regulatory submissions to both FDA and Health Canada requiring manual assembly
- Reportability decisions that were not standardised across the team
- Audit trails fragmented across multiple tools
- No system-enforced closure logic for complaints with open child records
How Smarteeva Solved It
Smarteeva deployed a role-based complaint management system where each team has precisely the access it needs.
- Five-Team Role Architecture: Quality owns the full complaint lifecycle. Regulatory controls decision trees and submissions. Customer Care handles intake and participates in approvals. Product gets read-only visibility for development decisions. Risk scores complaints independently with access limited to five risk fields.
- Automated Decision Trees: Two conditions execute without manual input. When the country is the US and the product is not manufactured by the company, the system records "not manufactured by the company" automatically. When the country is the US and severity is no harm, negligible, or minor, a second tree fires with "not reportable." Zero manual steps for non-reportable events.
- Direct FDA MDR Submission via NextGen API: MDRs are submitted directly to the FDA. The system tracks acknowledgements through three stages (ACK-1, ACK-2, ACK-3). A batch job runs every 20 minutes to process submissions and fetch acknowledgements. A manual "Submit to FDA" button allows immediate filing for urgent cases.
- Health Canada MIR Submission (4-Status Flow): MIR records follow a four-status workflow: Opened, Pending Approval, Approved, Submitted. A "Check Form" validation catches missing fields before submission. CVR records follow a similar flow with auto-populated fields from product registration.
- Auto-Population from Product Registration: Every regulatory record (MDR, MIR, CVR) auto-populates manufacturer details, device information, and regulatory classification from the linked product registration. Regulatory users fill only patient information and submission-specific fields.
- Smart Audit Trail on Every Object: Every field change across every object is tracked with timestamps, old values, new values, and the user who made the change. Colour-coded visual indicators show insertions, updates, and deletions. Meets 21 CFR Part 11 requirements for electronic record traceability.
What Changed
Before Smarteeva
- Regulatory submissions assembled manually from fragmented sources
- Reportability decisions unstandardised and dependent on who made them
- Five teams working across different tools with different views
- Audit trails scattered across multiple systems
- Complaint closure tracked manually, with no enforcement
After Smarteeva
- Submissions auto-populate from product registration and file directly to FDA and Health Canada
- Decision trees fire on conditions, with zero manual input for non-reportable events
- One platform where all five teams work inside the same complaint record
- Every field change tracked with timestamps, old and new values, and user attribution
- The system blocks closure until every child record is closed
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