Requirements Management
The Requirements section of P4SaMD is where you capture, organize, trace, and verify the software requirements for your medical device project. Work-item management is built into the platform, so no external ALM tool is needed. Open it by clicking Requirements in the left project sidebar.
Navigating the Requirements List
Switch between two views with the toggle at the top of the list. The tree view shows requirements in a collapsible hierarchy of named sections, useful for an overview of the full structure. The flat view shows all requirements as a sortable, filterable list, better for bulk review or for applying search and filter criteria quickly.
Each requirement carries a set of standard fields: an auto-generated ID, a title and description, a type (Functional, Non-Functional, or Interface), a priority (Must, Should, Could), and a status that progresses through the lifecycle. You can also assign a level (System or Software) to support IEC 62304 V-model traceability. Further fields are an assignee, labels for grouping, acceptance criteria, and an optional mockup reference.
Creating Requirements
To add a new requirement, click + New Requirement at the top of the list, or right-click a section in tree view and choose Add requirement. Fill in at minimum a title and a type, then save. New requirements are created in Draft status.
Sections are named header nodes that group related requirements. Click + New Section to create one, then drag requirements under it or create them directly within.
Requirement Lifecycle
Every requirement moves through four states: Draft → In Review → Approved → Verified. A Draft is still being written. Once ready, it moves to In Review for a designated approver to evaluate. After sign-off it becomes Approved. It reaches Verified once it is linked to passing test evidence confirming correct implementation. Change the status using the status control in the requirement detail view.
If a requirement becomes obsolete, use the Deprecate action in the detail view. Deprecation requires a mandatory rationale and triggers an automatic change request. The requirement is marked as deprecated and retained in the system for traceability and audit purposes.
To move a requirement to a different place in the hierarchy, use the Change parent action in the detail view. It opens a picker where you search for and select the new parent without leaving the requirement you're editing.
Traceability
P4SaMD maintains bidirectional traceability automatically. The requirement detail view lists linked software items (design elements that implement the requirement), linked risks (with a coverage indicator), and linked test cases (that verify it). It also shows the full change history: every edit made, by whom, and when.
Searching, Filtering, and Bulk Actions
Use the search bar to find requirements by title or ID. The filter panel narrows by type, status, quality level, and assignee. For large projects, the flat view with filters is the fastest way to work through a backlog.
You can also import requirements from a CSV file, for example when migrating from an external ALM tool or loading a pre-existing requirement set. Export the full list in standard formats for use outside P4SaMD.
CSV Import
Each row of a CSV import is validated individually. Valid rows are imported and errors are reported for the rejected ones, so you do not need to fix everything before any requirements are created. Error details are shown per row, so you can correct and re-import only the failed entries.
Quality Assessment
P4SaMD automatically assesses the quality of each requirement based on completeness and clarity. A quality badge appears next to each requirement in the list:
| Badge | Level | Meaning |
|---|---|---|
| ✅ Emerald | Very High | Complete, unambiguous, testable, and all fields populated |
| ✅ Blue | High | Adequate but may lack some optional fields |
| ⚠️ Amber | Low | Incomplete, ambiguous, or missing critical information |
Quality is re-evaluated automatically every time you create or update a requirement. The badge is hidden while the new score is being computed, then reappears with the updated level. No manual action is needed.
Where to go next