dtge-ecr-manager

name	dtge-ecr-manager
description	Create and manage Engineering Change Requests (ECRs) for medical device projects

ECR Management Service

Create, track, and coordinate Engineering Change Requests (ECRs) for medical device design history files.

Overview

The ECR Manager service:

1. Creates new ECR packages with proper numbering
2. Tracks ECR status through approval workflow
3. Links changes to affected documents
4. Coordinates document reviews
5. Triggers re-assessment when changes affect compliance

Usage

/dtge-ecr-manager create <project-path>               # Create new ECR
/dtge-ecr-manager status <project-path>               # Show ECR status summary
/dtge-ecr-manager status <project-path> ECR149        # Show specific ECR details
/dtge-ecr-manager review <project-path> ECR149        # Schedule/coordinate review
/dtge-ecr-manager close <project-path> ECR149         # Close completed ECR

ECR Workflow

CREATE → DRAFT → UNDER_REVIEW → APPROVED → IMPLEMENTED → VERIFIED → CLOSED
                     ↓
                 REJECTED → (revise) → UNDER_REVIEW

Create ECR

Step 1: Get Next ECR Number

Query existing ECRs in project to determine next number:

# Check 10-Design_Changes/ folders for existing ECRs
# Pattern: ECR{number}_{description}/

Step 2: Gather Change Information (LLM-guided)

Collect through conversation:

• Change Description: What is being changed?
• Reason for Change: Why is this change needed?
• Affected Documents: Which documents need revision?
• Regulatory Impact: Does this affect:
  • Intended use?
  • Safety/risk profile?
  • Labeling claims?
  • Predicate comparison?
• Risk Assessment: Does change require new/updated risk analysis?
• Verification/Validation: What testing is needed?

Step 3: Create ECR Package

Directory structure:

<project>/10-Design_Changes/ECR{number}_{short_description}/
├── ECR{number}_Form.md           # ECR form
├── ECR{number}_Impact_Assessment.md
├── affected_documents/           # Documents to be revised
├── verification/                 # Verification records
└── approval_records/             # Review and approval evidence

Step 4: Generate ECR Form

# Engineering Change Request

## ECR Information
| Field | Value |
|-------|-------|
| ECR Number | ECR{number} |
| Title | {short title} |
| Date Initiated | {date} |
| Initiated By | {name} |
| Status | DRAFT |

## 1. Change Description
{Detailed description of the change}

## 2. Reason for Change
{Justification for the change}

## 3. Affected Items

### 3.1 Affected Documents
| Document ID | Title | Current Rev | Action |
|-------------|-------|-------------|--------|
| DHFD-26 | SRS | R8 | Revise |
| DHFD-28 | Risk Analysis | R6 | Revise |

### 3.2 Affected Hardware/Software
| Component | Description | Change Type |
|-----------|-------------|-------------|

## 4. Regulatory Assessment

### 4.1 Impact on Intended Use
[ ] No impact on intended use
[ ] Affects intended use (describe):

### 4.2 Impact on Safety/Risk
[ ] No new hazards introduced
[ ] New hazards identified (update DHFD-28)
[ ] Existing risk controls affected

### 4.3 Impact on Predicate Comparison
[ ] No impact on substantial equivalence
[ ] Affects comparison (describe):

### 4.4 Standards Affected
| Standard | Impact | Action Required |
|----------|--------|-----------------|

## 5. Verification/Validation Plan
| Activity | Protocol | Status |
|----------|----------|--------|

## 6. Implementation Plan
| Task | Owner | Target Date | Status |
|------|-------|-------------|--------|

## 7. Approvals

### Initiation Approval
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Originator | | | |
| Project Lead | | | |

### Implementation Approval
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Engineering | | | |
| Quality | | | |
| Regulatory | | | |

## 8. Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 01 | {date} | Initial ECR | |

ECR Impact Assessment

When an ECR is created, automatically assess impact on:

DCA Re-evaluation

• Does the change affect device classification?
• Does the change add new applicable standards?
• Does the change affect existing DCA coverage?

Gap Analysis Trigger

• If change affects risk profile → re-run gap analysis for Risk Management domain
• If change affects user interface → re-run gap analysis for Usability domain
• If change affects software → re-run gap analysis for Software domain

Traceability Update

• Identify affected trace chains
• Flag documents needing revision
• Update registry.json with ECR association

Track ECR Status

Status Summary

ECR Status Summary - Higi Green Special 510(k)

Open ECRs: 3
  ECR149 - A&D BP Module Integration [UNDER_REVIEW]
  ECR150 - Cybersecurity Documentation [DRAFT]
  ECR151 - User Manual Updates [IMPLEMENTED]

Recently Closed: 2
  ECR148 - Storm Keypad Update [CLOSED - 2025-12-15]
  ECR147 - UI Resolution Changes [CLOSED - 2025-11-30]

Pending Actions:
  ECR149: Awaiting QA review (due: 2026-02-10)
  ECR150: Impact assessment incomplete
  ECR151: Verification testing in progress

ECR Details

ECR149 - A&D BP Module Integration

Status: UNDER_REVIEW
Created: 2026-01-15
Target Close: 2026-03-01

Affected Documents:
  ✓ DHFD-26 SRS R9 (revised)
  ✓ DHFD-27 SDS R10 (revised)
  ◐ DHFD-28 Risk Analysis R7 (in progress)
  ○ DHFD-30 Traceability (pending)
  ○ DHFD-89 User Manual (pending)

Verification Status:
  ✓ Unit testing complete
  ✓ Integration testing complete
  ○ System testing (scheduled: 2026-02-15)
  ○ Usability validation (scheduled: 2026-02-20)

Review Status:
  ✓ Engineering review: Approved (2026-01-28)
  ◐ QA review: In progress
  ○ Regulatory review: Pending

Coordinate Reviews

Schedule Review

/dtge-ecr-manager review Work/Clients/Qualira/Higi/special_510k ECR149

Review Coordination for ECR149:

Required Reviewers:
  - Engineering (risk analysis changes)
  - QA (verification adequacy)
  - Regulatory (impact assessment)

Documents for Review:
  1. DHFD-28 Risk Analysis R7 DRAFT
  2. ECR149_Impact_Assessment.md

Suggested review meeting: [propose date based on calendar]

Draft review request email? [Y/n]

Review Request Template

Subject: Review Request - ECR149 A&D BP Module Integration

Review Package: ECR149 A&D BP Module Integration
Review Type: Design Change Review
Target Date: {date}

Documents for Review:
1. [DHFD-28 Risk Analysis R7 DRAFT](link)
2. [ECR149 Impact Assessment](link)

Review Focus:
- Risk analysis completeness for new BP module
- Verification test coverage
- Regulatory impact assessment accuracy

Please provide comments by {date}.

Review Meeting: {date/time} (optional)

Close ECR

Pre-closure Checklist

ECR149 Closure Checklist:

Documents:
  [✓] All affected documents revised and approved
  [✓] Document revisions match ECR scope
  [✓] Registry.json updated

Verification:
  [✓] All verification activities complete
  [✓] All tests passed or deviations documented
  [✓] Verification records filed

Reviews:
  [✓] Engineering review complete
  [✓] QA review complete
  [✓] Regulatory review complete

Traceability:
  [✓] DCA updated if needed
  [✓] Traceability matrix updated
  [✓] Gap status updated if applicable

Ready to close ECR149? [Y/n]

Integration

With Gap Analysis

ECR creation can trigger gap re-assessment:

• Change to risk profile → Risk Management domain
• Change to UI → Usability domain
• Change to software → Software domain

With Document Creation

ECR provides context for /dtge-create-dhf:

• ECR number for document naming
• Change scope for content generation
• Affected requirements for traceability

With DCA

Significant changes may require DCA update:

• New standards become applicable
• Device classification changes
• New regulatory requirements identified

Project Integration

Higi Project ECR Tracking

ECR packages are stored in:

• original_510k/10-Design_Changes/ (ECR ≤135)
• prior_changes/10-Design_Changes/ (ECR 136-148)
• special_510k/10-Design_Changes/ (ECR 149+)

Regulatory Tasks Integration

ECRs feed into regulatory_tasks.json for project tracking:

{
  "ecr_id": "ECR149",
  "status": "under_review",
  "tasks": [
    {"id": "T-149-01", "description": "Update DHFD-28", "status": "complete"},
    {"id": "T-149-02", "description": "System testing", "status": "in_progress"}
  ],
  "blockers": [],
  "target_date": "2026-03-01"
}