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ClearPath Medical AI

AI-powered PFMEA analysis tool for medical device risk assessment

Overview

A secure, locally-hosted Process Failure Mode and Effects Analysis (PFMEA) tool that uses generative AI to analyze work instruction PDFs and generate comprehensive risk assessments for medical device manufacturing. Built in collaboration with Theta Tau Professional Engineering Fraternity.

This tool revolutionizes traditional PFMEA workflows by automating the analysis of work instructions, identifying potential failure modes, and calculating risk priority numbers (RPN) through an agentic AI pipeline—all while keeping sensitive medical data completely local and secure.

Key Features

  • ●PDF upload & parsing: extracts operation details, equipment, and control points from work instructions
  • ●Agentic AI analysis: multi-step self-validating pipeline (ANALYZE → RATE → VALIDATE → CORRECT → FINALIZE)
  • ●RPN calculation: implements exact risk prioritization matrix with severity, occurrence, and detection ratings
  • ●Interactive results table: sortable, expandable PFMEA results with detailed justifications
  • ●Export functionality: export results to CSV or Excel for documentation
  • ●100% local processing: all data stays on-premise—no external API calls or cloud services

Architecture

Backend

FastAPI (Python) with SQLite database for local storage

Frontend

React + TypeScript + Vite + TailwindCSS

LLM Engine

Ollama with local llama3.2:3b model

Security

Local-only processing, input validation, secure file handling

How It Works

1

PDF Upload

Upload work instruction PDFs containing manufacturing operations and procedures

2

Extraction

AI parser extracts structured data: operations, equipment, materials, and control points

3

Agentic Analysis

Multi-step AI pipeline analyzes each operation for potential failure modes with self-validation

4

Risk Rating

Calculates RPN using standardized PFMEA scales: Severity (1-5), Occurrence (1-5), Detection (1-5)

5

Review & Export

Interactive table with sortable results, detailed justifications, and CSV/Excel export

PFMEA Rating System

The tool uses standardized medical device PFMEA rating scales with a 5x5 matrix:

Severity (1-5)
Impact on product performance and manufacturing process
Occurrence (1-5)
Frequency/likelihood of failure happening
Detection (1-5)
Likelihood of detecting failure before it reaches the customer

Risk Levels

Low: No further controls required
Medium: Pursue additional controls or document
High: Apply controls, design/process change may be required

Security & Privacy

  • 🔒All processing happens locally—no data leaves your machine
  • 🔒PDF file validation (type, size, magic bytes)
  • 🔒Input sanitization before LLM prompts to prevent injection attacks
  • 🔒SQLite database stored locally with proper permissions
  • 🔒No authentication required (single-user local tool)
  • 🔒Compliant with medical device data handling requirements