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User Needs List

Use this User Needs List template to clearly document and organize the specific needs and expectations of users for your medical device, which is essential for guiding product development, design inputs, and ensuring regulatory compliance with ISO 13485 and IEC 62366-1. Complete this template early in the design control process to provide a solid foundation for usability engineering, risk management, and conformity with EU MDR requirements.
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User Needs List

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1. Purpose and Scope

This document provides the user needs for consectetur adipiscing elit. The user needs will serve as an input to the product development and design controls process as defined by SOP Design Control.

2. Regulatory References

  • EU MDR 2017/745
  • ISO 13485:2016 - Medical devices Quality management systems Requirements for regulatory purposes
  • IEC 62366-1:2015 - Medical devices Part 1: Application of usability engineering to medical devices

3. User Needs

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