Explanation

The introduction to MEMO is organized around two questions:

Why MEMO

Why MEMO explains the engineering problem: medical-device assurance depends on a connected argument, while design changes can leave requirements, architecture, risk, verification, and evidence describing different baselines.

What is MEMO

What is MEMO explains the ontology: its scenario-driven foundation, architecture layers, assurance disciplines, functions and typed relationships, model viewpoints and views, and methodology selection.

Read Why MEMO first, then continue to What is MEMO.