MedDeviceDocs GPT – AI Assistant for ISO 13485 & MDR Documentation

💼 What Is MedDeviceDocs GPT?

MedDeviceDocs GPT is a highly specialized AI assistant designed for regulatory professionals, technical writers, and quality managers working in the medical device industry.

It helps you save time, reduce documentation errors, and ensure full compliance with international standards like:

• ISO 13485:2016
• EU MDR 2017/745 (Annex II & III)
• FDA 21 CFR Part 820
• ISO 14971:2019 (Risk Management)

🔧 Key Features

✅ Document Generator – Create SOPs, CAPA reports, PMS plans, risk files & more

✅ Audit Review Mode – Simulate feedback from Notified Bodies or FDA inspectors

✅ Checklist Mode – Ensure your documents meet compliance structure

✅ Tone Optimizer – Adapt your text to ISO-style clarity

✅ Quiz & Learning – Test your MDR/ISO knowledge in seconds

✅ Junior Mode – Simplified guidance for new technical writers

✅ Multilingual Support – Accepts input in 🇬🇧 🇩🇪 🇫🇷 🇳🇱 🇪🇸 🇵🇱 🇧🇬 – replies in English for regulatory consistency

📦 Bonus Materials Included

• 🧾 Quick-start PDF Guide
• 🗂️ 5 Regulatory Document Templates (editable)
• ✅ Printable ISO 13485 Compliance Checklist
• 📘 MDR/ISO Cheat Sheet (most used terms & clauses)

👨‍💼 Who Is It For?

• Regulatory Affairs professionals
• Freelance technical writers
• QA/RA consultants
• Notified body liaisons
• MedTech startups & OEMs

Whether you're preparing documentation for an EU submission or an FDA audit — MedDeviceDocs GPT becomes your on-demand writing partner.

⚙️ Requirements

• No ChatGPT Plus required for basic use
• GPT-4 file upload functionality requires Plus (for analyzing documents)
• English interface (input accepted in multiple languages)

🛒 License & Use

• One-time purchase, lifetime access
• Includes future updates
• Personal and small team license