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.
python validation fda cybersecurity samd medical-device regulatory-affairs iec62304 iso14971 iq-oq-pq
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Updated
May 17, 2026 - Python