samd

Atmel SAM: development platform for PlatformIO

Electronic Cats Package Lists for the Arduino Board Manager

Open-source, GitHub-native eQMS baseline for medical device and regulated software teams. Issues, PRs, Actions, and Releases form the quality system of record. Covers ISO 9001, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, ISO/IEC 27001, ISO/IEC 42001, GDPR/nFADP, plus an optional GAMP 5 / 21 CFR Part 11 overlay.

MicroPython LoRa EBYTE E22 device library complete and tested with Arduino SAMD, esp8266, esp32, Raspberry, rp2040 and STM32. sx1262/sx1268

MicroPython library for pcf8574 an i2c digital expander for Arduino, esp32, SMT32 and ESP8266. Can read write digital values with only 2 wire.

XAC compatible USB joystick using TinyUSB

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.

Design-control checks for software teams — traceability, verification, SOUP and releases, as CI gates.

MicroPython Library to use pcf8591 i2c analog IC with Arduino, Raspberry Pi Pico and rp2040 boards, esp32, SMT32 and ESP8266. Can read analog value and write analog value with only 2 wire.

Software-as-a-Medical-Device research prototype for AI-assisted intracytoplasmic sperm injection (ICSI). Two-stage YOLOv8 pipeline (multi-class detection plus polygon segmentation) to support sperm selection, immobilization, and injection. Django web app with live and recorded video annotation.

Atmel SAM: development platform for PlatformIO

Python toolkit for generating FDA/IEC-compliant SaMD validation packages — IQ/OQ/PQ protocols, ISO 14971 risk management, IEC 62304 lifecycle, SBOM, and cybersecurity checklists.

AI-powered risk classification tool for life sciences use cases under the EU AI Act — maps to Annex III high-risk categories, ISO 42001 controls, and EU MDR/IVDR obligations for CDx and SaMD programs. Includes multi-model comparison (Claude + GPT-4o-mini + Gemini).

AI tool that drafts auditable, FDA-grounded verification & validation plans for 510(k) medical devices — AI proposes, deterministic rules enforce, humans approve.

Transformer-based NLP symptom classification for clinical triage — with AI governance analysis (ISO 42001 / NIST AI RMF), FDA SaMD regulatory pathway assessment, calibration validation, and bias audit framework. TRL 3 prototype → deployment roadmap.

FDA GMLP + PCCP validation evidence for ML-based Software as a Medical Device: drift detection, subgroup fairness, PCCP change evaluation with three-band confidence routing. FastAPI + React.

Design History File traceability matrix for SaMD: requirements → design → verification → validation → ISO 14971 risk controls, ingesting ML validation evidence from ml-samd-validator with three-band link confidence. FastAPI + React.

EU AI Act compliance classifier for healthcare AI — Claude + rules engine, with demo mode and BYOK

Real-time diagnostic pattern analysis and Software as a Medical Device (SaMD) modeling for neuroendocrine signaling matrices. Built strictly on deterministic physiological equations, biometric scaling formulas, and synthetic validation data. Contains no patient protected health information (PHI).