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Medical Devices · Workflow
Product lifecycle management and change control
This workflow automates the end-to-end product lifecycle management and change control process for medical devices, ensuring regulatory compliance and quality standards while accelerating product development timelines.
Workflow Trigger
Engineering change request (ECR) is submitted for an existing medical device product
Visual Flow
Each node represents an automated step. Connections show how data and decisions move through the workflow.
Step-by-Step Breakdown
Detailed explanation of each automated stage in the workflow.
- 1Trigger
ECR Submission Received
An engineering change request is automatically captured and validated for completeness. Initial routing to appropriate stakeholders begins based on device classification and change scope.
- 2Action
Impact Assessment Generation
Automated analysis evaluates the change impact across regulatory, quality, manufacturing, and clinical domains. Risk scoring algorithms determine required approval levels and documentation needs.
- 3Decision
Regulatory Review Required
Decision point determines if the change requires FDA submission, CE marking updates, or other regulatory notifications based on predefined classification rules.
- 4Action
Quality Documentation Update
Automatically updates Design History Files, Device Master Records, and quality procedures. Version control ensures all stakeholders access current documentation.
- 5Action
Post-Market Surveillance Sync
Updates post-market surveillance protocols and complaint handling procedures to reflect product changes. Historical performance data is analyzed for trending.
- 6Action
Manufacturing Release Authorization
Generates updated manufacturing instructions, validates supplier requirements, and releases approved changes to production systems with full traceability.
- 7Output
Change Control Completion Package
Delivers comprehensive change documentation package including regulatory submissions, updated quality records, and manufacturing authorization with full audit trail.
Outputs
- Updated Device Master Record with version control
- Regulatory submission package (510k/CE marking)
- Manufacturing change authorization with traceability
- Post-market surveillance protocol updates
Key Metrics
- Change control cycle time
- Regulatory submission accuracy rate
- Manufacturing deviation incidents post-change
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