This document outlines your user needs, also known as “stakeholder requirements.” These form the initial stage of requirements mapping and represent the highest level of design input. Describe the broad requirements that your device must fulfill. Subsequently, these user needs will be translated into software requirements that detail the technical specifications of your product.
You may use alternative tools such as Jira or GitHub issues for this task. Just make sure that the content (i.e., the columns presented here) is maintained in a similar structure.
Mapping Standard Requirements to Document Sections
| ISO 13485:2016 Section | Document Section |
|---|---|
| 7.2.1 | (All) |
| 7.3.3 | (All) |
| IEC 62366-1:2015 Section | Title | Document Section |
|---|---|---|
| 5.2 | Identify user interface characteristics related to safety and potential use errors | 1 |
| 5.6 | Establish user interface specification | 1 |
1. User Needs
When defining user needs, consider the following factors:
- Regulatory compliance requirements.
- Functional use requirements for product safety and performance to ensure its intended use.
- Risk management requirements: include all hazard-related use cases that must be tested during usability evaluations (see the last column on the right for details).
| User Need ID | User Group | Requirement Description | Safety-Critical? |
|---|---|---|---|
| 1 | User | The software provides a score predicting the likelihood of contracting Covid based on (…). | Yes |
| 2 | User | Users can access instructions for use or reach out to support for assistance. | Yes |
| 3 | Company | The software can be integrated with various laboratory systems in the intended operating environment. | No |
| 4 | Regulatory | The device must be developed in line with relevant regulations, standards, and norms (e.g., IVDR/MDR, GDPR, HIPAA). | No |
| 5 | (…) | (…) | (…) |