An open-source alternative to proprietary regulatory consulting platforms for medical software classification. It utilizes interactive decision logic to map software features against FDA and EU MDR 2017/745 regulatory requirements.
Tech Stack
HTMLMedical Devices
Why samd-regulatory-navigator?
• Transparent regulatory decision logic
• Zero licensing or subscription costs
• Supports local data hosting for privacy
Limitations
• No legal liability coverage
• Requires manual updates for law changes
• Lacks integrated document management
1/27/2026
Last Update
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License
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