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

/dca <project-path>              # Create new DCA for project
/dca <project-path> --update     # Update existing DCA
/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>/dca.json Schema: ~/Documents/DTGE/Work/workflow/schemas/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

Gap Analysis

After DCA is created, run /gap-analysis to:

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

Document Creation

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

Project Management

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

Example: Blood Pressure Device

User: /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