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Views and Evidence

The model is the source; a view is a purposeful selection of it. Build each view for a review question, not simply to display every element.

Review question Useful view
Who and what interact with the device? System context
How does a clinical scenario unfold? Operational sequence
Which functions cooperate for an outcome? Functional chain
Which component owns each responsibility? Function allocation
How are components connected? Logical or physical interconnect
How does a hazard lead to harm and where is it controlled? Risk chain
Which requirements lack tests? Verification coverage
Which software depends on which third-party packages? Software architecture or SBOM view

A view is not a second model

Do not copy elements into diagram-specific packages merely to make a picture. Reference canonical elements and relationships. Layout metadata may change without changing engineering meaning.

Depth is a view decision, not a model decision

Composite states and composite actions are model structure: a state owns substates, an action owns steps, and those relationships are real. How much of that depth a reader unfolds is not.

Keep the two apart. Declaring depth on a view says what it offers by default; folding a composite to a single box, or drilling into one so it becomes its own diagram, is a reading move made at the renderer. Neither rewrites the model, and neither should be recorded as if it did. A deep hierarchy is not a modelling error to be flattened — it is content the reader navigates.

Evidence closes the loop

A useful assurance path is:

flowchart LR
    Claim[Requirement or RiskControlMeasure] -->|VerifiedBy| Case[VerificationCase]
    Case -->|ProducesEvidence| Evidence[Evidence]
    Evidence --> Result[Result, version, approval, and location]

Record enough metadata to reproduce and review the result:

  • procedure and version;
  • tested configuration;
  • acceptance criteria;
  • actual result;
  • anomalies or deviations;
  • evidence location and approval status.

Use views to expose missing links, then use the underlying model to correct them.

Continue the story

Read the GPCA case study to see the same path—from clinical scenario through architecture, risk, and evidence—in a complete reference model, documented as an ISO/IEC/IEEE 42010 architecture description.