Medical Device Receiving Inspection Automation

Automates the receiving inspection workflow for medical device companies operating under ISO 13485 / FDA 21 CFR Part 820. Designed to run inside Claude Code.

What it does

Given a Purchase Order folder containing shipping docs, drawings, and certificates, this tool:

1. Scans all subfolders and matches documents to each part by part number
2. Extracts data from POs, packing slips, receiving lists, COCs, and CAD drawings
3. Cross-references all documents for consistency (part#, rev, lot, qty, dates)
4. Fills a Quality Product Release Form (PRF) Excel template automatically
5. Compiles all documents for each part into one ordered PDF package
6. Exports the PRF as PDF with correct header, logo, and fonts on every page

Folder structure expected

PO26-0085/
├── PO26-0085.pdf
├── Shipping Docs/          ← packing slips, receiving list
├── Drawings/               ← one CAD drawing PDF per part
├── COCs/                   ← vendor COCs, sterilization COCs, travelers
├── In-Progress/            ← compiled PDFs output here (created automatically)
└── Inspections/            ← PRF Excel + PDF output here (created automatically)

Subfolder names are detected by content — they don't need to match exactly.

Quick start

1. Install dependencies

pip install anthropic pdfplumber openpyxl pymupdf

Also install LibreOffice for PDF export.

2. Set your Anthropic API key

Windows: Add ANTHROPIC_API_KEY as a User Environment Variable under Settings → System → Environment Variables.

Mac/Linux:

export ANTHROPIC_API_KEY="sk-ant-..."

3. Place required files

Put these in your working Receivings/ folder (parent of all PO folders):

• CLAUDE.md — this file (Claude Code reads it automatically)
• QF_7_4_3-02_Rev_E_template.xlsx — your PRF Excel template

4. Run

Open Claude Code in your Receivings/ folder and type:

process PO26-0085

Claude Code reads CLAUDE.md, scans the PO folder, processes every part on the order, and outputs a filled PRF + compiled PDF for each.

Output per part

File	Location	Purpose
PRF-[PART]_Rev_[X].xlsx	Inspections/	Filled Excel — add measurements, get signatures
PRF-[PART]_Rev_[X].pdf	Inspections/	PDF version with header/logo on every page
PO##-##### Receiving Part X - [PART].pdf	In-Progress/	Compiled receiving package

PRF auto-fill coverage

Section	Auto-filled	You fill
1.1 Part info	✓ PO#, supplier, date, part#, rev, lot, qty	Inspector signature
1.2 Qty inspected	✓ N/A or 100% checkbox	AQL / qty if applicable
1.3 QDA	✓ N/A or YES/NO	Last QDA date if applicable
2.1–2.6 Checklist	✓ All checkboxes with logic	—
3 Data report	✓ Characteristics, limits, gaging method	Measured values (blue cells)
4 Comments	✓ Off-the-shelf notes, DVT references	Any additional notes
5 Discrepancies	✓ N/A or flagged issues	—
6 Disposition	✓ Raw/Finished goods checkbox	QM signature

Adapting to your QMS

The CLAUDE.md is the core — edit it to match your:

• PRF template — update cell coordinates in Step 8 if your form differs
• Signing workflow — update Step 7 and the "What the engineer does after" section
• Vendor rules — update Special Cases with your confidential vendor list
• Document numbering — update the header stamp in Step 9

Requirements

• Python 3.10+
• Claude Code (https://docs.claude.com/claude-code)
• Anthropic API key (https://console.anthropic.com)
• LibreOffice (https://libreoffice.org) — for PDF export

Security note

CLAUDE.md enforces strict file access — Claude Code can only read/write files inside the folder it was opened in. It will never access files outside the PO folder tree.

License

MIT — adapt freely for your quality management system.