Architecture Views

Visualize the System to Provide a Holistic Understanding of the Medical Device

What Are Architecture Views?

Architecture views are designed to visually represent your project in order to communicate abstract ideas from multiple points of view in ways that make it easy for others to understand. Architecture views provide benefits to software development teams and other stakeholders to ensure everyone has an understanding of the system at the level that's important to them.

Architecture views illustrate relationships between parts of the system as well as the dataflows and boundaries within it. The views should identify security-relevant medical device system elements and their interfaces as well as defining security context, domains, boundaries, critical user roles and external interfaces. Adaptiv Risk makes it easy to satisfy the architecture view requirements.

  • Interactive: Adaptiv Risk contains an interactive, drag-and-drop architecture designer. No third-party tool required.
  • Ready to Go: Tailor-made designer built for eSTAR modeling.
  • Traceability: The FDA expects to see traceability from architecture views to other aspects of the cybersecurity requirements. Adaptiv Risk makes that easy with built-in traceability capabilities.

Architecture views are an FDA requirement when filing a 510(K) so creating and maintaining accurate diagrams is an important aspect of medical device development. Contact us if you want to learn more about Adaptiv Risk's architecture modeling.

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