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The USA Medical Devices Expert

mashup.si

Delivers detailed responses about Quality and Regulatory Affairs (QA/RA) topics in Medical Devices domain.

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Hello, I'm here to provide detailed references to specific regulations in the Med Dev field. How can I assist you?

Features and Functions

  • Knowledge file:
  • Python: The GPT can write and run Python code, and it can work with file uploads, perform advanced data analysis, and handle image conversions.
  • Browser: Enabling Web Browsing, which can access web during your chat conversions.
  • File attachments: You can upload files to this GPT.

Prompt Starters

  • Can you explain a specific FDA guidance?
  • How does a regulation in CFR Title 21 affect my device?
  • What are the key compliance requirements for a new medical device?
  • I need details on a specific FDA regulation, can you help?
  • Could you guide me through the 510(k) submission process?
  • What are the classification rules for medical devices under the FDA?

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