software-as-a-medical-device

Here are 3 public repositories matching this topic...

bryan-basg / samd-starter-kit

SaMD Starter Kit — build Software as a Medical Device with an AI agent team. IEC 62304 + ISO 14971 compliance scaffolding, 10 specialized agents, multi-agent workflows, and a complete regulatory Design History File. For Claude Code.

fda healthcare starter-kit hipaa samd gdpr risk-management medical-device ai-agents iec-62304 iso-14971 iso-13485 digital-health healthtech regulatory-compliance software-as-a-medical-device claude-code medical-device-software

Updated Aug 9, 2026
Python

api-evangelist / brightinsight

Star

BrightInsight is a regulated digital health platform for biopharma and medtech. Its cloud-based, microservices platform captures, transmits and analyzes data from CE-marked and FDA-regulated medical devices, combination products, apps and Software as a Medical Device (SaMD) in compliance with global security, privacy and regulatory requirements.

company healthcare regulated compliance medtech medical-devices digital-health apis-json software-as-a-medical-device biopharma

Updated Aug 12, 2026

api-evangelist / microhealth

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Microhealth is a Y Combinator (S15) digital-health company building digital therapeutics and connected patient-provider networks for people living with rare bleeding disorders such as hemophilia and for sickle cell disease.

company healthcare real-world-evidence digital-health digital-therapeutics apis-json hemophilia software-as-a-medical-device patient-engagement sickle-cell-disease bleeding-disorders

Updated Aug 12, 2026

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