meMO
Layer 01 · Ontology + Methodology Published preview
A domain ontology for safety-critical medical devices: purpose-built for regulated systems where architecture, risk, verification, and evidence must stay connected. SysML v2 provides the language. meMO provides the medical-device vocabulary and method.
Architecture + assurance
Five architecture layers move from operational intent to realization, while requirements, safety, cybersecurity, human factors, verification, and validation remain connected across the lifecycle.
Installation
$ npm install --save-exact @memoarchitect/ontology@0.11.2
Requires Node.js 20 or later. This content-only package provides the portable SysML v2 ontology and methodology; it contains no runtime engine. View the package on npm.
Safety-relevant concepts are typed definitions and usages with regulator-relevant attributes: IntendedUse, ReasonablyForeseeableMisuse, SafetyRelatedCharacteristic, HazardCause, Hazard, SequenceOfEvents, HazardousSituation, Harm, Risk, RiskControlMeasure, ResidualRisk, Benefit, Requirement, Architecture, Behavior, VerificationCase, and Evidence.
Every relation is a native SysML v2 connection def —
its name is the verb, its typed ends carry the roles. DerivesFrom,
SatisfiedBy, MitigatesHazard, VerifiedBy, ProducesEvidence.
Rules walk required semantic links and flag missing paths. Every hazard needs a control. Every control needs verification. Every verification needs evidence. Gaps surface before design review.
Package structure
memo::Operational context, functions, behavior, logical structure, interfaces, software, hardware, deployment, and physical realization.
Needs and requirements, safety risk, cybersecurity, human factors, verification, validation, and their evidence.
Artifact definitions, change and postmarket records, document views, and ISO 14971 risk-management-file content.
Identity, terminology, dimensions, controlled values, common semantic bases, and typed relationships.
Profiles, patterns, rules, workflows, gates, archetypes, and project-specific method resolution.
Closure, coverage, cross-layer, lifecycle, ontology, and quantitative rules plus reusable diagram and document views grouped by viewpoint.
Semantic links
Methodology
ResolvedMethodology keys scope to SafetyClassKind (A/B/C) and lifecycle stage — not a rigor dial.
Viewpoints per audience and workflow stage; a View binds that intent to content.
ElementUsageRule and RelationUsageRule carry a RuleStrengthKind; WorkflowSteps and QualityGate exit criteria.
ProjectMethodBinding pins a resolved method, with reusable ModelingPatterns and archetypes.