dtge-generate-dca

name: dtge-generate-dca description: Create and manage Design Compliance Analysis (DCA) for medical device regulatory projects

Design Compliance Analysis (DCA)

Create, update, and manage Design Compliance Analysis documents for medical device projects. The DCA identifies applicable standards and maps requirements to V-Model deliverables.

Overview

The DCA is a per-project deliverable that:

1. Identifies which standards apply to THIS device based on classification
2. Pulls applicable clauses from the Master Standards Database
3. Assigns traceability IDs (DCA-001, DCA-002...) to each requirement
4. Maps DCA items to V-Model stage deliverables
5. Becomes the foundation of the full traceability matrix

Usage

/dtge-generate-dca <project-path>              # Create new DCA for project
/dtge-generate-dca <project-path> --update     # Update existing DCA
/dtge-generate-dca <project-path> --status     # Show DCA coverage status

Workflow

Step 1: Device Characterization (LLM-guided)

Gather device information through conversation:

• FDA device classification (Class I, II, III)
• FDA product code and regulation number
• Intended use statement
• Software involvement (yes/no, safety class if yes)
• Predicate device (for 510(k))
• Use environment and user population

Step 2: Standards Identification

Based on device characterization, query the Master Standards Database:

Location: ~/.claude/data/regulatory-standards/

Key files to query:

• applicability/device-class-matrix.json - Standards by FDA class
• applicability/software-level-matrix.json - IEC 62304 requirements
• v-model-mapping/stage-mapping.json - Clause to deliverable mapping

Always applicable for Class II/III:

• 21 CFR 820.30 (Design Controls)
• ISO 14971:2019 (Risk Management)
• IEC 62366-1:2015 (Usability)

Conditional:

• IEC 62304 (if software present)
• IEC 60601-1 (if medical electrical equipment)
• Device-specific particulars (e.g., IEC 80601-2-30 for NIBP)

Step 3: Generate DCA Requirements Matrix

For each applicable standard, pull clauses from:

• fda/21cfr820/clauses.json
• iso/14971-2019/clauses.json
• iec/62366-1-2015/clauses.json
• iec/62304-2015/clauses.json

Assign DCA IDs sequentially: DCA-001, DCA-002, DCA-003...

Step 4: Map to V-Model Stages

Using v-model-mapping/stage-mapping.json, assign each DCA item to:

• V-Model stage (00-11)
• Expected deliverable type
• Typical document IDs

Step 5: Generate Outputs

DCA JSON file: <project>/dtge-generate-dca.json Schema: ~/Documents/DTGE/Work/workflow/schemas/dtge-generate-dca.schema.json

DCA Markdown document: <project>/DCA_Design_Compliance_Analysis.md

DCA Document Template

# Design Compliance Analysis
## {Project Name} - {Device Description}

### 1. Device Classification
- FDA Classification: {Class}
- FDA Product Code: {Code}
- Software Safety Class: {Class or N/A}
- Predicate Device: {510(k) number}

### 2. Applicable Standards Summary
| Standard | Version | Scope | Rationale |
|----------|---------|-------|-----------|

### 3. Compliance Requirements Matrix
| DCA ID | Standard | Clause | Requirement | V-Model Stage | Expected Deliverable | Status |
|--------|----------|--------|-------------|---------------|---------------------|--------|

### 4. Gap Summary
| DCA ID | Gap Status | Gap ID | Notes |
|--------|------------|--------|-------|

### 5. Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|

Integration with Other Services

Document Audit

After DCA is created, run /dtge-doc-audit to:

• Compare DCA requirements against existing documents
• Identify missing or incomplete coverage
• Generate gap report

Document Creation

Use /dtge-create-dhf to generate documents that satisfy DCA requirements.

Project Management

Use /dtge-ecr-manager to track changes that affect DCA compliance.

Example: Blood Pressure Device

User: /dtge-generate-dca Work/Clients/Qualira/Higi/special_510k

Claude: I'll create a DCA for the Higi project. Let me gather device information...

Device Characterization:
- FDA Class II (Product Code: DXN)
- Predicate: K172739
- Contains software (Class B)
- Medical electrical equipment
- Blood pressure measurement

Applicable Standards:
1. 21 CFR 820.30 - Design Controls
2. ISO 14971:2019 - Risk Management
3. IEC 62366-1:2015 - Usability Engineering
4. IEC 62304:2006+A1:2015 - Software Lifecycle (Class B)
5. IEC 60601-1 - Medical Electrical Safety
6. IEC 80601-2-30 - NIBP Particular Standard
7. ISO 81060-2 - NIBP Validation

Generated DCA with 87 requirements across 11 V-Model stages.
Coverage status: 62 covered, 8 partial, 17 gaps

Notes

• DCA is a living document - update when standards change or device scope changes
• Link DCA items to actual documents as they're created/updated
• Use DCA as input to gap analysis workflow
• DCA traceability chain: DCA-xxx → DHFD-xx → Test Case → Validation