Every requirement, BOM line, risk, test result, and supplier relationship is a node in one graph. An AI layer drafts and challenges; a human approval gate gates every change; a deterministic core holds the audit trail.
AI proposes. The graph enforces. The human decides.
Avera Core is the system of record — immutable, audited, 21 CFR Part 11 compliant. Avera AI sits above it and never writes directly. Every suggestion is queued for a human to approve, revise, or reject.
Proposes, challenges, improves.
Drafts risk analyses, V&V protocols, submission sections. Claude via MCP. Context-scoped to the nodes it touches.
↓ Human approval gate ↓
System of record.
Immutable audit trail. Electronic signatures (eIDAS, ZertES). Graph-native traceability. 21 CFR Part 11.
No training on customer data. Every API call audited. Per-item opt-in at the node level.
The graph is the source of truth. The AI is an assistant with a leash. The human is the final approver of every change.
Relationships are first-class citizens — not foreign keys. Impact analysis is a traversal, not a report. This is structural, not a feature.
Change a design input and every affected design output, V&V protocol, risk control, and submission section surfaces instantly. No JOIN queries. No nightly exports. No stale trace matrix.
Traceability is computed from the graph at read time. There is no trace matrix to reconstruct before an audit — the matrix is a projection of the graph, always current.
Claude via MCP, scoped to the nodes it touches. Every output routes through the human approval gate. Every API call is logged.
Risk analyses, V&V protocols, submission sections, test-procedure skeletons, FMEA entries. Generated from live graph context, not a blank page.
Continuously checks for orphaned items, missing traces, contradictions across DHF / DMR / technical files. A quality layer, not just a generator.
Customer data is never used to train any model. AI use is opt-in at the node level. Every transmission to Anthropic is logged with node scope, timestamp, and human reviewer.
DHF, DMR, technical files, and submission sections authored as live documents — tables and sections bound to graph queries, updated as the underlying nodes change.
510(k), eSTAR, and MDR technical files generated from live graph data. A queryTable inside a document pulls from the graph at render time, not at authoring time.
Avera appears as a mounted filesystem. SolidWorks, Altium, MATLAB, Jira, Confluence read and write through it — no plugin, no connector, no integration project.
US vs EU configurations. Next-gen exploration alongside the current release. A three-way merge engine with explicit conflict resolution on every node type.
A field complaint links instantly to the affected BOM line, risk control, V&V protocol, and regulatory filing. The loop from complaint to design input — the one every team intends and few close — closes by construction.
The closed loop is not a workflow. It is a graph traversal.
One platform where previously there were three — and the connective tissue that stitched them was spreadsheets.
Send us a sanitized slice of your current requirements and BOM. We'll show it to you as a graph.
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