Pinpoint context
Find first. Read second.
Instead of dumping massive manuals into an AI context window, tools and agents pull only the relevant sections and relationships, then open the exact code, model, test, or evidence directly.
Medical Device Software · FDA-Ready Quality System
The fastest path to FDA approval for medical device software.
Preparing medical device software for FDA clearance or approval shouldn't mean halting engineering to assemble 500-page paper binders. The Tinverse Quality System embeds compliance directly into your development workflow. Keep engineering decisions and their evidence connected from your first code commit to your final submission—giving regulators the crystal-clear traceability they demand, while letting developers ship with confidence.
Zero Audit Scramble
Design controls and traceability matrices update automatically alongside code.
FDA QMSR & IEC 62304
Turnkey SOPs and schemas tailored for 510(k), De Novo, or PMA filings.
AI-Ready & Traceable
Equip engineering agents with verified, source-backed context without hallucination.
Built for modern startups
Start with a working quality-system structure, then make it yours.
You don't need to reinvent compliance from a blank page. The Tinverse Quality System gives you a ready-to-run foundation—proven procedures, clear record schemas, and complete traceability out of the box—tailored for the FDA pathway that fits your product roadmap. Your team stays firmly in the driver's seat: you own the device, operate the quality system, produce your own engineering evidence, approve every record, and handle your FDA submission. (Our framework provides the structure and tooling; it does not choose a pathway or guarantee authorization.)
Tailor
Shape the system to your device and team
Set your intended use, assign clear team roles, define your software lifecycle, and establish supplier controls. Adopt the procedures that match your real development process.
Develop
Create evidence as the product changes
Connect requirements, hazards, risk controls, code changes, dependencies, unit tests, and release gates as you build. When audit day comes, your traceability matrix is already complete—no frantic forensic archeology.
Review
Catch gaps and broken links long before auditors do
Deterministic checks automatically flag orphaned requirements, unverified risk controls, and outdated documentation directly in CI. Fix issues during routine code reviews when they take minutes to resolve, not weeks.
Submit
Assemble clear, credible submission packages
Pull reviewed, version-locked evidence straight into your regulatory dossier. The same cohesive records support your 510(k), De Novo, PMA, IDE, or international filing.
Every medical device follows its own regulatory journey. A 510(k) demonstrates substantial equivalence to a legally marketed predicate device, whereas an IDE authorizes clinical investigations rather than granting marketing clearance. The right submission path depends on your device classification, intended use, available predicate devices, and whether clinical evidence is required—and our structured framework keeps your technical documentation audit-ready whichever route you take.
Agentic engineering support
Give AI developer agents the context they need—without the noise. When an agent works in your codebase, it doesn't have to wade through a 500-page unstructured document dump. It queries the exact requirement, algorithm, safety gate, or verification evidence required for the task. Every result names its verified source, exact file location, git revision hash, and trust level—keeping automation grounded, fast, and reliable.
One controlled workflow
Queryable for work. Readable for review.
Controlled inputs
Clean, versioned Git history
Every change is recorded with versioned schema snapshots and migrations. You get stable identities, clear relational links, and a transparent, reviewable Git audit trail.
Focused retrieval
Retrieve a traceable context package
Stop hunting through nested folders. Exact IDs, full-text search, and relational graph links pinpoint the exact technical context immediately. Optional local semantic search supports smart developer queries—and every result leads straight back to an approved source document, never an unverified index.
Across products
Follow one engineering question across the stack
Need to understand why an embedded controller has a specific safety cutoff? Follow the question seamlessly from the clinical risk analysis down through software requirements, architecture models, source files, and unit tests across all your repositories.
Measured retrieval
Test the questions engineers actually ask
We test documentation the way you test code. Real-world engineering queries—like finding the requirement behind a test failure or the evidence behind a release gate—run as automated CI checks to catch stale sources and broken links.
Human review
Transparent, byte-checked Markdown
No proprietary database lock-in. Everything compiles into clean, byte-checked Markdown that your team can read and diff using standard pull requests, while automated build gates immediately reject stale views.
Clear provenance
Know where every answer came from.
Every excerpt carries its source identity, file location, revision hash, sensitivity, and trust classification. You always know who wrote it, when it was approved, and how it connects to the product.
Instruction safety
Retrieved text cannot direct the agent.
Keep strict security boundaries. Retrieved documents, code comments, and bug logs are treated strictly as evidence—they can never hijack prompt instructions or override your engineering rules.
Full traceability
Follow the reason for a change.
Move seamlessly from an FDA release gate back to its parent requirements, algorithms, safety obligations, unit tests, and test runs—without manually stitching spreadsheets together.
Continuous consistency
Reject drift early.
Schema constraints, relational integrity checks, artifact validation, and deterministic rendering catch disconnected requirements and broken tests right in your everyday builds.
Self-contained repos
Keep evidence beside the implementation.
Each product repo houses its own engineering evidence and tests alongside the code. A checkout stands on its own—fully buildable, testable, and ready for audit.
Medical-device lifecycle
A practical structure for controlled software work.
We built this system around real medical-device software standards: FDA's Quality Management System Regulation (QMSR), ISO 13485 (Quality Management), IEC 62304 (Software Lifecycle), ISO 14971 (Risk Management), and IEC 81001-5-1 (Health Software Cybersecurity). It gives your team a cohesive, audit-ready framework for design and development records. While it does not certify a product or replace your team's risk calls, clinical validation, regulatory strategy, or FDA submission, it makes producing compliant evidence a natural part of shipping software.
Engineering agents help you retrieve, compare, and check controlled context in seconds. But people stay in command: Accountable people still approve changes and sign completed records.
Ready to accelerate your FDA clearance?
Whether you're starting a new device program or preparing an upcoming 510(k) or De Novo submission, let's talk about how Tinverse can streamline your quality system.