Insight & Suggestions

P4SaMD ensures compliance with IEC 62304 rules by analyzing Software Items, Requirements, Risks, and Tests.
It detects inconsistencies and suggests modifications to improve compliance and reduce risks.

Overview

Each suggestion includes:

• Gravity Check:
  • Error: Actions that must be performed;
  • Warning: Recommended actions to improve compliance;
  • Info: Optional actions to enhance software quality;
• Issue Resolution: The actions needed to resolve the detected issue;
• Actionable Guidance: Instructions on what must be done;
• Standard Reference: The applicable IEC 62304 requirement, including the paragraph number, title, and explanation.

Suggestions Rules

Software Items

For Software Items suggestions, visit the Software Items page.

Requirements

IEC 62304 Reference Requirement	Title	Description
[5.7.4] Evaluate SOFTWARE SYSTEM testing	Missing Tests	Each Requirement must be associated with at least one test.

Tests

IEC 62304 Reference Requirement	Title	Description
[5.7.1] Establish tests for software requirements	Test not executed	This test has not been executed.
[5.7.5] SOFTWARE SYSTEM test record contents	Missing Information in the Last Execution	The last execution of the manual test must include all mandatory information.
-	Missing Execution Mode	The test Execution Mode (automatic or manual) is not specified.

Risks

IEC 62304 Reference Requirement	Title	Description
[7.2.1] Define RISK CONTROL measures	Missing Risk Control Measures	Risks associated with Software Items of class B or C must be linked to at least one Requirement as a Risk Control Measure.

Suggestions Indicators

Two types of icons can appear in the Suggestions column of tables:

Icon	Meaning
	One or more child Software Items have suggestions. Only for Software Items.
	The number of suggestions for the entity. Hovering over it reveals a clickable menu that links to the Suggestions Drawer section.