SAMD Starter Kit (github.com)

The SAMD Starter Kit has been launched as a comprehensive framework for developing Software as a Medical Device (SaMD) projects, particularly targeting Class B applications. This kit offers a collection of templates, compliance rulesets, and workflow methodologies that enable developers to create SaMD from scratch without the usual complexities of regulatory compliance, testing, and traceability. Its interactive setup facilitates the classification of software and guides users through filling out essential documentation while adhering to IEC 62304 and ISO 14971 standards. Significantly, this kit addresses the challenges faced by solo founders, health software startups, and medtech companies by providing a structured approach to regulatory compliance from the outset. It incorporates specialized AI agents designed to handle various aspects of software development and compliance, ensuring that every technical decision aligns with SaMD requirements. Essential features include a persistent memory structure, CI/CD workflows, and a Design History File (DHF) that tracks regulatory materials. By distilling real-world experience from a production Class B SaMD platform, the kit aims to prevent newcomers from encountering common pitfalls and to streamline the operational processes necessary for health software development.