Small context
Find first. Read second.
Agents receive a limited set of relevant sections and relationships, then open the named code, model, test, or evidence directly.
Tinverse Quality System
Keep engineering decisions and their evidence connected.
Medical-device software teams need more than documents in folders. The Tinverse Quality System links requirements, risk controls, architecture, tests, dependencies, anomalies, and release inputs to the products they describe. People retain readable documents; automation gets precise, queryable records.
For a startup
Start with a working quality-system structure, then make it yours.
A company can adopt and tailor the Tinverse Quality System to control product development and organize evidence for the FDA pathway identified by its regulatory strategy. It supplies procedures, record structures, and traceability; the manufacturer still owns the device, operates the quality system, produces device-specific evidence, approves the records, and submits to FDA. It does not choose a pathway or guarantee authorization.
Tailor
Define the product and how the team will control it
Set the intended use, accountable roles, development lifecycle, supplier controls, records, and applicable procedures for the actual device program.
Develop
Create evidence as the product changes
Connect requirements, hazards, risk controls, architecture, software changes, dependencies, verification, anomalies, and releases instead of reconstructing the history before a review.
Review
Find missing or stale work early
Deterministic checks expose disconnected requirements, unverified controls, stale views, and incomplete release inputs while the work is still inexpensive to correct.
Submit
Assemble reviewed inputs for the chosen pathway
The same controlled records can support preparation of a 510(k), De Novo, PMA, IDE, or another appropriate submission.
A 510(k) asks FDA to determine substantial equivalence to a legally marketed device. An IDE governs an investigation used to collect clinical evidence; it is not marketing clearance. The appropriate FDA submission depends on the device’s classification, intended use, available predicate devices, and whether clinical evidence is required.
Agentic engineering support
An agent that can work in a repository can ask for one requirement, algorithm, gate, or evidence neighborhood instead of loading the entire documentation tree. Each result names its source, exact location, freshness, trust level, and relationship to the work.
One controlled flow
Queryable for work. Readable for review.
Controlled inputs
Append-only changes
Versioned schema snapshots and project migrations preserve stable identities, relationships, and a reviewable Git history.
Focused retrieval
Retrieve a traceable context package
Exact identities, full-text search, and engineering relationships find the relevant material first. Optional local semantic search supports retrieval-augmented agent workflows. Every result leads back to a reviewed source instead of making an index the source of record.
Across products
Follow one engineering question across the stack
Repository manifests and federated search connect the quality system with product requirements, algorithms, models, source locations, tests, and evidence while preserving the owner and instructions of each repository.
Measured retrieval
Test the questions engineers actually ask
Each product keeps retrieval examples for real work: finding the requirement behind a test, the evidence behind a gate, or the algorithm behind a failure. Coverage and stale-source checks run with the normal engineering gates.
Human review
Deterministic documents
Database-owned content renders back to byte-checked Markdown. Reviewers can read and diff ordinary documents while automated checks reject stale views.
Clear provenance
Know where an answer came from.
Source identity, location, revision, content hash, sensitivity, and trust classification travel with every retrieved excerpt.
Instruction safety
Retrieved text cannot direct the agent.
Documents, code comments, logs, and external material are treated as evidence. Repository and user instructions remain a separate authority boundary.
Traceability
Follow the reason for a change.
Move from a product gate to its requirements, algorithms, formal obligations, tests, and evidence without reconstructing the chain by hand.
Consistency
Reject drift early.
Schema locks, relational constraints, artifact checks, and deterministic rendering catch stale or disconnected engineering information in normal builds.
Product delivery
Keep evidence beside the implementation.
Each product owns its engineering evidence and pins the shared catalog contract, so a checkout remains buildable and reviewable on its own.
Medical-device lifecycle
A practical structure for controlled software work.
The process and evidence structure is designed around FDA's Quality Management System Regulation and ISO 13485, IEC 62304, ISO 14971, and IEC 81001-5-1 workflows. It helps teams assemble consistent design and development records; it does not certify a product or replace the device manufacturer's risk decisions, approvals, validation, regulatory strategy, or submission.
Engineering agents can retrieve, compare, and check controlled context. Accountable people still approve changes and sign completed records.
Contact engineering@tinverse.com.