An open-source Python-based generator suite for AIAG-VDA 2019 Process Failure Mode and Effects Analysis (pFMEA). It automates compliance documentation for medical device manufacturing under ISO 13485 and 21 CFR 820.
Tech Stack
PythonLegal & Compliance
Why pfmea-template?
• Automates complex AIAG-VDA calculations
• Pre-configured medical device scenarios
• Generates clean Excel reports via openpyxl
Limitations
• CLI-only interface
• Requires Python knowledge to customize
• No collaborative web UI
5/17/2026
Last Update
0
Forks
0
Issues
Unknown
License
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