ECR Management Service

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

Overview

The ECR Manager service:

•Creates new ECR packages with proper numbering
•Tracks ECR status through approval workflow
•Links changes to affected documents
•Coordinates document reviews
•Triggers re-assessment when changes affect compliance

Usage

code

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

ECR Workflow

code

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:

bash

# 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:

code

<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

markdown

# 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

code

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

code

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

code

/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

markdown

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

code

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 /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:

json

{
  "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"
}