Template: Software Requirements List

This document pertains to your product, and it should be linked to it for clarity. A straightforward approach is to place all product-related documents into a folder within your Quality Management System (QMS) to maintain a clear association. Alternatively, you could specify the relevant product and version here, but this would require updating each time a new release occurs, which can be cumbersome.

This list contains your software requirements. If your system includes multiple components (e.g., a frontend and a backend), use the “Software System” column for identification. The categories align with IEC 62304 section 5.2.2. The Risk Control Measure? column is a simple yes/no field, and the related risk IDs should reference your risk table.

Alternatively, you may use tools such as Jira or GitHub Issues, provided that the structure (i.e., the columns shown here) is maintained.

Mapping of Standard Requirements to Document Sections

1. Software Requirements

While IEC 62304 primarily requires documenting software requirements, ISO 13485 also mandates documenting high-level customer requirements. One way to meet this requirement is by creating a two-tier hierarchy: user stories (representing the ISO 13485 customer requirements) at the first level, and technical specifications (representing the IEC 62304 software requirements) at the second level.

Displaying this in a single table can be difficult, so the provided table focuses solely on software requirements. You may choose to create a separate table for user stories or combine them within this table as needed.