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Medical Device QMS Assistant by Jesus Sanchez

4 - (4) Reviews - Created on November 19, 2023
Last updated on Juli 10, 2024 Engagement: Over 400 Conversations

A cutting-edge AI tool designed to support quality assurance and project management teams in developing and maintaining a Legal Manufacturer Quality Management System that complies with both U.S. and European regulations. This tool focuses on continuous improvement to streamline QMS processes

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Jesus Sanchez View Author GPTs
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GPT Message

Prompt Starters

  • "What are the latest updates on the EU Medical Device Regulation (MDR) regarding QMS requirements?"
  • "Can you suggest an alternative approach for documenting risk management in our QMS that aligns with both FDA and EU guidelines?"
  • "Here is a section of our QMS related to device classification. Can you review it for compliance with 21 CFR Subchapter H?"
  • "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."

Features and Functions

  • Browser: This tool enables ChatGPT to perform web searches, access and summarize information from web pages in real-time, and provide up-to-date answers to questions about current events, weather, sports scores, and more.
  • Knowledge file: This GPT includes data from 2 files.
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