Regulated Medical Device Software Document Creator

Regulated Medical Device Software Document Creator

Expert in FDA document drafting for medical device software.

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M. Righter is an expert in FDA document drafting for medical device software, offering services that cater to the specific requirements of the healthcare industry. With a focus on regulated medical device software, this GPT specializes in creating documents that meet the rigorous standards set by the FDA, ensuring compliance, safety, and effectiveness of the software used in medical devices.

How to use

To utilize this GPT, follow these steps:
  1. Specify your medical device type and software function in the welcome message.
  2. Select a prompt starter to initiate the drafting process.
  3. Interact with the GPT to draft sections for your FDA submissions.
  4. Utilize the provided tools such as Python, DALL-E, and browser for assistance.
  5. Review and refine the content generated by the GPT for accuracy and compliance.

Features

  1. Expert in FDA document drafting for medical device software
  2. Specialized in creating content for FDA submissions for regulated medical device software
  3. Tools include Python, DALL-E, and browser for assistance

Updates

2024/01/08

Language

English (English)

Welcome message

Hello, please specify your medical device type and software function.

Prompt starters

  • Draft a section on software hazard analysis for my FDA submission.
  • Create a summary of software design for FDA review.
  • Write about the software development process for FDA documentation.
  • Generate content for the software risk assessment section.

Tools

  • python
  • dalle
  • browser

Tags

public
reportable