Tin eQMS · AI-assisted quality management
Preparing for FDA review shouldn't mean wading through static binders of SOPs. Tin eQMS brings an intelligent conversational assistant to your medical-device quality workspace—letting you ask plain-English questions, inspect the exact clauses behind every answer, and collaborate on draft reviews in real time. Get the speed of AI with the audit rigor of version-locked documents and accountable human decisions.
Early-access development. The hosted preview is available to enrolled reviewers.
Ask in plain language
Wondering how your team handles software anomalies, or looking for specific document-control rules? Just ask. Built-in fuzzy search finds the right procedures even if you don't remember the exact SOP number or acronym. A dedicated assistant floats right alongside your document view so you never lose your place.
Retrieval-first AI
No guesswork or hallucinations. Before answering, the system retrieves verified clauses directly from your approved quality documents. Inspect referenced documents, read rendered Markdown, and compare versions while you evaluate the answer.
Human accountability
AI suggests, but humans make the call. The preview binds confirmed draft comments to your Google identity and the exact document version. Edit suggestions and draft review requests follow the same explicit confirmation pattern.
A conversation with context
Chat isn't just for searching—it's for doing real work. Use the assistant to navigate procedures, summarize key clauses, and draft proposed revisions side-by-side with your source documents. AI-assisted answers remain material for your review; the original evidence stays accessible right in front of you.
Conversational workflows · Preview
Streamed answers and confirmed draft actions keep work moving smoothly. Each proposed change has a clear scope, a version-specific preview, and an audit-ready receipt once confirmed.
The assistant drafts an exact-text edit. Inspect the difference side-by-side before choosing whether to save it as a draft suggestion.
The server checks the logged-in reviewer, source version, and confirmation. A saved suggestion preserves the proposed text, its predecessor hash, and an attributable receipt. The frozen baseline stays intact.
Choose an enrolled reviewer and confirm the draft review request. The owner and assigned reviewer can reopen the saved suggestion, compare notes, and collaborate.
These examples describe draft collaboration in the preview. Formal QMS approval and signing have separate authorization requirements.
Client-selectable AI
Medical device teams have strict data security boundaries. Our modular adapter architecture lets you choose where and how AI runs—from local offline lookups to private on-prem models or managed cloud providers—while permissions, confirmations, and document records stay safely inside the eQMS.
Start local
Fast offline catalog retrieval and direct SOP counts provide a quick starting point with zero external AI API calls or cloud dependencies.
Bring your AI
Already run a private on-prem LLM or dedicated cloud endpoint? Connect through a client adapter to route requests through your own infrastructure. Each integration is qualified for your environment.
Configure remote AI
Our turnkey cloud pilot connects directly to Gemini on Google Cloud Vertex AI, featuring granular request budgeting and deployment-controlled credentials.
One organization, connected product work
The Tinverse Quality System provides the regulatory rules, procedures, and governance structure. Tin eQMS is the day-to-day web application your team uses to run those processes across all your product workspaces. Product repositories retain full ownership of their code, tests, risk matrices, and release evidence.
Our roadmap brings that engineering evidence together with full lifecycle document workflows, training tracking, CAPA investigations, and submission dossier assembly. Regulatory transmission remains a separately authorized activity.
Capability status
Tin eQMS is in active preview development. Intended-use assurance, organizational adoption, and operational authorization remain separate requirements. Organizations retain responsibility for their quality decisions, validation, and regulatory obligations.
Ready to see how conversational quality management can accelerate your team? Let's discuss your document workflows, evidence sources, deployment requirements, and preferred AI setup.
