Medical Device QMS Assistant on the GPT Store
Introduction to Medical Device QMS Assistant
With its extensive knowledge base and intuitive interface,
Whether you need assistance with device classification, record-keeping requirements, or aligning your QMS with industry standards,
GPT Description
GPT Prompt Starters
- "What are the latest updates on the EU Medical Device Regulation (MDR) regarding QMS requirements?"
- "How can this GPT help my work? Can you provide more information?"
- "How can we improve our current QMS documentation process to better meet continuous quality improvement standards in the medical device industry?"
- "Provide a comparison of QMS record-keeping requirements between the U.S. and Europe."
- "Here is a section of our QMS related to device classification. Can you review it for compliance with 21 CFR Subchapter H?"
- "Can you suggest an alternative approach for documenting risk management in our QMS that aligns with both FDA and EU guidelines?"
Medical Device QMS Assistant GPT FAQs
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