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MEDTech | Consultant - Prompt of the Week: Enhancing Software Quality in Medical Devices

Software Quality Prompt

Ensuring software quality and compliance with international standards is paramount.

Our Prompt of the week delves into how this tool can be utilized to review software code, focusing on adherence to international standards.

How the Prompt Works

To leverage the MEDTech | Consultant for code review, users must provide a detailed description of their software code and specific compliance concerns.

The refined prompt, tailored for compliance reviews, asks users to describe the application of the code and to highlight any particular international standards they wish to adhere to.

The tool then conducts a thorough review, identifying potential compliance issues and offering improvements aligned with industry best practices.

By following the prompt's structured approach, engineers can significantly improve the quality and compliance of their software, thereby contributing to the development of safe and effective medical devices.

Step-by-Step Guide to Using the Prompt

  1. Define Your Software: Briefly describe your software's application. For instance, is it a diagnostic tool, patient monitoring system, or another type of medical device software?

  2. Specify Compliance Needs: Clearly state the international standards you are targeting, such as ISO 13485 for quality management systems or IEC 62304 for software lifecycle processes.

  3. Submit Your Code: Provide the code you need reviewed. Ensure it's well-documented to facilitate an accurate review.

  4. Review and Implement Suggestions: Once the tool provides its feedback, review the suggestions carefully and plan for implementation in your software development process.

  5. Iterative Improvement: Use the feedback not just for immediate improvements but also to inform your long-term development and compliance strategies.

MEDTech | Consultant PROMPT

Hello MEDTech | Consultant, I am a software quality engineer and require your expertise in reviewing the attached code. This code is part of a [briefly describe the application, such as a patient monitoring system, diagnostic tool, etc.]. I need specific guidance on ensuring the code complies with relevant international standards, such as ISO 13485, ISO 14971, IEC 62304, or any other applicable standards in the medical device industry. Please provide a detailed overview of this uploaded code, highlighting any areas that may not be in compliance with these standards and suggest improvements. Also, if possible, advise on best practices for documentation and testing procedures to support compliance.


MEDTech | Consultant - iDE8 and OpenAI, collectively referred to as "the Providers," do not assume any liability for the information provided by this GPT, referred to as "the System." Users are advised to exercise caution, cross-reference, and independently validate the information obtained from the System. The System is not a validated source for medical device development, quality, regulatory affairs, or any other critical matters. For validated and expert support in these areas, users are encouraged to contact By using the System, users acknowledge and accept the inherent limitations and risks associated with AI-generated content.


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