Medical Device QMS Assistant
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
💬 2+ Chats
Use This GPT📝 Builder Details
- Name: Jesus Sanchez (View More GPTs By This Builder)
👋 Welcome 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."
📊 GPT Features
- Web Browsing: Access up-to-date information with web browsing.
- File Upload: You can upload files to this GPT.
📚 Browse Related GPTs
Regulated Medical Device Software Document Creator
Expert in FDA document drafting for medical device software.
💬 4+ Chats
MDR Medical Device Classifier
Suggests the correct MDR classification for your medical device based on the MDR Annex VIII Classification Rules. Please provide a description of your...
💬 10+ Chats
Medical Device Regulatory Advisor
Expert in EU/US med device regs, IVDR, ISO standards, MDR, FDA, with online referencing.
💬 10+ Chats
Mango :Medical Device Development Leadership Coach
Leadership and medical device development coach for engineers
💬 3+ Chats
Medical Device Regulations Expert
Expert on EU Medical Device Regulations (MDR), In Vitro Medical Device Regulations (IVDR) & Medical Device Single Audit Program (MDSAP)
💬 1+ Chats
Medical Device GPT
💬 3+ Chats
Medical Device Specialist
Expert in medical device information, providing precise details and sterilization guidelines.
💬 0+ Chats
QMS Builder
Expert in IEC 62304 & ISO 13485, aiding in Quality Management System implementation.
💬 5+ Chats
