BMAD Medical Device Module (BMMD)

SaMD Regulatory Compliance Extension for BMAD Method


BMAD Medical Device (BMMD) extends the BMAD Method with specialized agents, workflows, and documentation templates for developing Software as a Medical Device (SaMD) in compliance with international regulatory standards.

Regulatory Frameworks Supported

- IEC 62304 - Medical device software lifecycle
- ISO 14971 - Application of risk management to medical devices
- IEC 62366-1 - Usability engineering for medical devices
- FDA 21 CFR Part 820 - Quality System Regulation
- FDA 21 CFR Part 803/806 - Medical Device Reporting & Corrections
- EU MDR 2017/745 - Medical Device Regulation (including PMS/PMCF)
- IMDRF SaMD - Software as a Medical Device classification

Prerequisites

- Node.js >= 20.0.0
- BMAD Method >= 6.0.0 installed in your project

Installation

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``bash


First, ensure BMAD Method is installed

npx bmad-method install

Then install BMAD Medical Device module

npx bmad-md install
`

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`bash
npm install -g bmad-md
bmad-md install
`

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The installer will:
- Copy 10 specialized agents to _bmad/bmmd/agents/
- Install 11 regulatory workflows
- Create document templates and checklists
- Generate Claude Code commands in .claude/commands/

After installation, agents are accessible via /bmad-agent-bmmd-* commands in Claude Code.

Using the Agents

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After installation, invoke agents using the slash commands:

`
/bmad-agent-bmmd-regulatory-affairs # Launch Dr. Régis
/bmad-agent-bmmd-risk-manager # Launch Dr. Hana
/bmad-agent-bmmd-clinical-evaluator # Launch Dr. Claire
/bmad-agent-bmmd-quality-manager # Launch Quentin
/bmad-agent-bmmd-cybersec-officer # Launch SecureMax
/bmad-agent-bmmd-pms-officer # Launch Dr. Vigil
/bmad-agent-bmmd-human-factors # Launch Prof. Didac
/bmad-agent-bmmd-data-governance # Launch Daria
/bmad-agent-bmmd-biostatistician # Launch Dr. Gauss
/bmad-agent-bmmd-ai-ethics # Launch Dr. Aequitas
`

Each agent will present an interactive menu with specialized workflows and templates.

Specialized Agents

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| Agent | Code | Specialty |
|-------|------|-----------|
| Dr. Régis | regis | Regulatory Affairs Specialist (FDA, CE, MDR) |
| Dr. Hana | hana | Risk Manager (ISO 14971, FMEA) |
| Dr. Claire | claire | Clinical Evaluator |
| Quentin | quentin | Quality Manager (IEC 62304, QMS) |
| SecureMax | securemax | Cybersecurity Officer |
| Dr. Vigil | vigil | Post-Market Surveillance (PMS, PMCF, Vigilance) |
| Prof. Didac | didac | Human Factors & Training (IEC 62366, IFU) |

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| Agent | Code | Specialty |
|-------|------|-----------|
| Daria | daria | Data Governance Officer |
| Dr. Gauss | gauss | Biostatistician |
| Dr. Aequitas | aequitas | AI Ethics & Fairness Officer |

Regulatory Workflows

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- /regulatory-scoping - Define regulatory strategy and target markets
- /samd-classification - Classify device per IMDRF, FDA, and MDR

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- /risk-management-cycle - ISO 14971 hazard analysis and risk control
- /prd-regulatory-enrichment - Enrich PRD with regulatory requirements
- /architecture-safety-review - IEC 62304 safety and security review

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- /clinical-validation - Design clinical validation protocol
- /story-regulatory-gate - Pre/post implementation compliance checks

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- /design-history-assembly - Compile Design History File (DHF)
- /submission-package - Prepare regulatory submission (510(k), CE Technical File)

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- /post-market-surveillance - PMS Plan, PMCF, PSUR, Vigilance
- /usability-engineering - IEC 62366-1 process, formative/summative evaluations

Templates Included

- Intended Use Statement - Regulatory intended use/purpose template
- Hazard Analysis (FMEA) - ISO 14971 compliant hazard analysis
- Traceability Matrix - Requirements to test case traceability
- SOUP Evaluation - Software of Unknown Provenance assessment
- Regulatory Story Addendum - Story-level compliance documentation

Compliance Checklists

- IEC 62304 Phase Gate Checklist
- Story-Level Regulatory Compliance
- Release Readiness (Medical Device)
- AI/ML Model Validation Checklist

Governance Policies

- SOUP Governance Policy
- AI-Assisted Development Policy
- Patient Data Handling Policy
- Clinical Significance Thresholds

Project Structure

After installation, BMMD creates the following structure:

`
.bmad/
└── bmmd/
├── config.yaml # Module configuration
├── module-help.csv # Help documentation
├── agents/ # Specialist agent definitions
│ ├── regulatory-affairs.md
│ ├── risk-manager.md
│ ├── clinical-evaluator.md
│ ├── quality-manager.md
│ ├── cybersec-officer.md
│ ├── post-market-surveillance.md
│ └── human-factors.md
├── workflows/ # Regulatory workflows
│ ├── regulatory-scoping/
│ ├── samd-classification/
│ ├── risk-management-cycle/
│ ├── post-market-surveillance/
│ ├── usability-engineering/
│ └── ...
├── templates/ # Document templates
├── checklists/ # Compliance checklists
└── policies/ # Governance policies
`

Workflow Diagram

The BMMD workflow integrates with standard BMAD phases:

!BMAD-MD Workflow

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`
┌──────────────────────────────────────────────────────────────────────────────────────┐
│ BMAD-MD Full SaMD Lifecycle │
├─────────────┬─────────────┬─────────────────┬─────────────────┬──────────────────────┤
│ Phase 1 │ Phase 2 │ Phase 3 │ Phase 4 │ Phase 5 │
│ Discovery │ Definition │ Development │ Delivery │ Post-Market │
├─────────────┼─────────────┼─────────────────┼─────────────────┼──────────────────────┤
│ Brainstorm │ PRD-MD │ Story Reg Gate │ DHF Assembly │ PMS Plan (Art. 84) │
│ Research │ Risk Mgmt │ Clinical Valid │ Submission Pkg │ PMCF (Art. 61) │
│ Brief │ Arch Review │ Story Cycles │ 510(k)/CE File │ PSUR (Art. 86) │
│ Reg Scope │ Usability │ Usability Eval │ │ Vigilance │
│ SaMD Class │ IFU Draft │ │ │ AI Perf Monitoring │
├─────────────┼─────────────┼─────────────────┼─────────────────┼──────────────────────┤
│ R1 │ R2 │ R3 │ R4 │ Continuous │
├─────────────┴─────────────┴─────────────────┴─────────────────┴──────────────────────┤
│ Agents: Dr. Régis, Dr. Hana, Dr. Claire, Quentin, SecureMax, Dr. Vigil, Prof. Didac │
└──────────────────────────────────────────────────────────────────────────────────────┘
`

Phase 5 - Post-Market is critical for MDR compliance and includes:
- Dr. Vigil: PMS Plan, PMCF, PSUR, Vigilance reporting, AI/ML performance monitoring
- Prof. Didac: IFU maintenance, user training updates, usability feedback integration

CLI Commands

`bash


Check installation status

npx bmad-md status

Install module (with options)

npx bmad-md install --force # Overwrite existing
npx bmad-md install --verbose # Show detailed output

Remove module

npx bmad-md uninstall
``

Integration with BMAD Method

BMMD workflows complement the core BMAD Method (BMM) workflows:

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1. Mary's Discovery (BMM) → Regulatory Scoping (BMMD)
2. Product Brief (BMM) → SaMD Classification (BMMD)
3. PRD Creation (BMM) → PRD Regulatory Enrichment (BMMD)
4. Architecture (BMM) → Architecture Safety Review (BMMD)
5. Story Development (BMM) → Story Regulatory Gate (BMMD)
6. UX Design (BMM) → Usability Engineering (BMMD)

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7. Release → Post-Market Surveillance Plan activation
8. Production Monitoring → AI Performance Monitoring (drift, decay)
9. Customer Feedback → Vigilance & PMCF integration
10. Periodic Reviews → PSUR generation

License

MIT License - see LICENSE for details.

Contributing

Contributions are welcome! Please read the contributing guidelines before submitting PRs.

Support

- GitHub Issues
- BMAD Method Documentation