bmad-md

v1.3.1

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19 hours ago

BMAD Medical Device Module - SaMD regulatory compliance extension for BMAD Method

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sayrel13

bmad medical-device samd iec-62304 iso-14971 fda ce-marking mdr regulatory compliance healthcare ai-agents

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

Via npx (Recommended)

# First, ensure BMAD Method is installed
npx bmad-method install

# Then install BMAD Medical Device module
npx bmad-md install

Via npm

npm install -g bmad-md
bmad-md install

What Gets Installed

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

In Claude Code

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

Core Regulatory Agents

| 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) |

AI/ML Extension Agents

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

Regulatory Workflows

Phase 1 - Discovery (Gate R1)

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

Phase 2 - Definition (Gate R2)

/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

Phase 3 - Development (Gate R3)

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

Phase 4 - Delivery (Gate R4)

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

Phase 5 - Post-Market (Continuous)

/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

Full Lifecycle Overview (including Post-Market)

┌──────────────────────────────────────────────────────────────────────────────────────┐
│                           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

# 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:

Pre-Market (Phases 1-4)

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

Post-Market (Phase 5 - Continuous)

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

License

MIT License - see LICENSE for details.

Contributing

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