How Welldoc Built a Five-Team Complaint Management System with Automated FDA and Health Canada Submissions on Smarteeva
Welldoc develops BlueStar, an FDA-cleared prescription digital therapeutics platform for people living with diabetes. As a software-as-a-medical-device (SaMD) company operating across the US and Canada, Welldoc needed a post-market surveillance system that matched the complexity of its regulatory environment without requiring a large compliance team.
Welldoc's BlueStar platform is an FDA-cleared, CE-marked digital therapeutic used by patients with type 2 diabetes. The product operates as a software-as-a-medical-device, which means 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 Welldoc's product matured and regulatory obligations grew, the team recognized 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 standardized 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 they need:
- 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 auto-execute without manual input. When the country is the US and the product is not manufactured by Welldoc, the system answers "not manufactured by Welldoc" 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 submit directly to FDA. The system tracks acknowledgments 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. Color-coded visual indicators show insertions, updates, and deletions. Meets 21 CFR Part 11 requirements for electronic record traceability.
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