SaMD Starter Kit

SaMD Starter Kit provides a comprehensive framework for developing Software as a Medical Device (SaMD) with a focus on integration with AI agents. It simplifies the complex requirements of IEC 62304 and ISO 14971 compliance by offering pre-configured templates and a structured methodology designed to streamline your development process.

Key Features:

• Specialized AI Agents: Leverage a diverse team of ten AI agents, each tailored to specific layers of the development process, including backend, frontend, security, and regulatory auditing. Each agent is equipped with rules and workflows that assist in maintaining compliance while building your software.
• Compliance by Design: The kit embeds a compliance-first mentality into every aspect of development. By ensuring traceability, rigorous testing, and risk management at each stage, the kit helps to guard against potential issues that could arise during or after deployment.
• Complete Regulatory Design History File (DHF): Access a robust set of over 40 templates covering essential documents required for regulatory submission, from safety classifications to clinical evaluations and post-market support. These templates are designed to adapt to the unique requirements of your project.
• Multi-Agent Workflows: The integrated workflows enhance collaboration and effectiveness among the AI agents. Processes such as adversarial verification and audit trails are automated, ensuring that all changes and updates are documented appropriately for compliance.
• Field-Proven Methodologies: The kit draws upon real-world experience from production environments, offering insights into common pitfalls and effective strategies for navigating the medical device landscape.

Getting Started:

To begin utilizing the SaMD Starter Kit, clone the repository using the following commands:

git clone https://github.com/bryan-basg/samd-starter-kit my-medical-device
cd my-medical-device
rm -rf .git && git init -b main   # start your own history
bash scripts/init_kit.sh       # interactive and re-runnable to fill placeholders

Visit the Getting Started guide for a detailed walkthrough of the setup process, including classification of your software, filling in foundational documents, and understanding the daily operational loop with the AI agents.

Ideal For:

• Startups and Solo Founders: This kit is particularly beneficial for entrepreneurs in the health software space who prefer not to navigate the complexities of regulatory compliance alone.
• Established MedTech Companies: Organizations seeking a robust, reusable scaffold for meeting the stringent demands of medical software development will find significant value.
• AI Development Teams: Teams focused on leveraging AI capabilities in healthcare software will benefit from the pre-configured agent ensemble tailored to SaMD requirements.

Summary:

The SaMD Starter Kit is an essential resource for anyone involved in the creation of software intended for medical use. It provides not just the tools for development, but also embeds essential regulatory practices directly into coding workflows, ultimately aiming to accelerate the path to compliance and deployment. For more details, explore the full documentation and examples provided in the repository.