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 directly into the platform — no external ALM tool is needed. Open it by clicking Requirements in the left project sidebar.
Navigating the Requirements List
Requirements can be browsed in two views, switchable via the toggle at the top of the list. The tree view shows requirements organized in a collapsible hierarchy of named sections, which is useful for getting an overview of the full structure. The flat view shows all requirements as a sortable, filterable list — better for bulk review or when you need to apply 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, attach an assignee, apply labels for grouping, define acceptance criteria, and optionally link a 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. To impose structure, you can create sections — named header nodes that group related requirements — by clicking + New Section and then dragging requirements under them or creating 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. Finally, once it is linked to passing test evidence that confirms it has been implemented correctly, it reaches Verified. You 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, triggers an automatic change request, and marks the requirement as deprecated while retaining it in the system for traceability and audit purposes.
Traceability
P4SaMD maintains bidirectional traceability automatically. In the requirement detail view you can see all linked software items (design elements that implement the requirement), linked risks (with a coverage indicator), linked test cases (that verify it), and a full change history showing 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 lets you narrow by type, status, quality level (if Smart Insight is enabled), 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 — useful for migrating from an external ALM tool or loading a pre-existing requirement set — and export the full list in standard formats for use outside P4SaMD.
Where to go next