# Traceable Docs > Traceable Docs (the product is called Traceable) is requirements traceability and document control software for regulated product teams. Write in a document-style workspace while every requirement stays linked, every change stays controlled and every approval is recorded, so evidence is audit ready. Traceable is built for teams working to standards such as IEC 62304, ISO 13485 and ISO 14971. It is aligned with what those standards expect of documentation. It does not itself make an organisation compliant or certified. ## Documentation - [Working with an AI assistant (MCP)](https://traceabledocs.com//docs/ai-assistant-mcp): AI and integrations. Connect Claude, ChatGPT or Cursor to your projects, and what it can and cannot do. - [MCP connector reference](https://traceabledocs.com//docs/mcp-reference): AI and integrations. The full connector manual: access, connecting from each client, the consent screen, and all 25 tools in detail. ## AI assistants and MCP - [AI Connector (MCP)](https://traceabledocs.com//mcp): Connect Claude or another AI assistant to your Traceable account, inside the same controls as your team. - MCP server endpoint: https://app.traceabledocs.com/api/mcp/mcp (streamable HTTP, OAuth 2.1). Requires a Traceable account whose organisation admin has enabled MCP access. Nothing is readable before authentication. ## Markdown versions - [Home page (Markdown)](https://traceabledocs.com//index.md): What Traceable Docs is, who it is for, its key capabilities and a pricing summary. - [Pricing (Markdown)](https://traceabledocs.com//pricing.md): Every plan with its per-author monthly and annual prices, limits, inclusions and trial terms, from the same data as /pricing. - [AI Connector (Markdown)](https://traceabledocs.com//mcp.md): The connector endpoint, authorisation, how to get access and connect, and the full tool list from the server registry. - Every documentation article is also served as Markdown, at its own URL with .md appended (for example /docs/.md). ## Product - [Traceable Docs](https://traceabledocs.com//): What Traceable Docs is: requirements traceability and document control for regulated product teams. - [Contact](https://traceabledocs.com//contact): Book a demo, ask about a pilot plan, or contact the team. - [About us](https://traceabledocs.com//about): The company that makes Traceable, Traceable Docs Pty Ltd, and what it is for. - [Security and privacy](https://traceabledocs.com//security): How Traceable protects customer data, how it is tested, and the standards it is built to align with. States plainly that no security certification is held yet. - [Brand assets](https://traceabledocs.com//brand): The Traceable logo, app icon and mark in SVG and PNG at permanent URLs, with brand colours and usage guidance. The product is Traceable; the company that makes it is Traceable Docs. - [Get started](https://traceabledocs.com//get-started): Configure a plan (tier, billing and authors), see the estimated price, and send an enquiry. - [Requirements management software](https://traceabledocs.com//requirements-management-software): How requirements are authored, versioned and traced in Traceable. - [Document control software](https://traceabledocs.com//document-control-software): Controlled documents, revisions, review and approval. - [Requirements traceability matrix](https://traceabledocs.com//requirements-traceability-matrix): What an RTM is and how Traceable keeps one live rather than rebuilt for audits. - [Requirements management software with MCP](https://traceabledocs.com//requirements-management-software-with-mcp): What an AI assistant can do in Traceable through MCP (read and draft, never publish or sign), the controls that keep its work reviewable, and what it costs. - [Pricing](https://traceabledocs.com//pricing): Plans and prices. Reviewers and Auditors are free; you pay for the people who author. - [ROI calculator](https://traceabledocs.com//roi-calculator): Estimate the hours and cost your design documentation takes each year, against Traceable, net of the subscription. A model built from a step-by-step map of twelve document processes. - [Solutions](https://traceabledocs.com//solutions): Who Traceable is for. - [For medical device teams](https://traceabledocs.com//solutions/medical-devices): Requirements and design control for teams working to IEC 62304 and ISO 13485. - [For medical device startups](https://traceabledocs.com//solutions/medical-device-startups): Low-cost requirements management for early-stage medical device teams: the Free plan and per-author prices, design controls, a live traceability matrix and e-signatures. - [For regulatory consultants](https://traceabledocs.com//solutions/regulatory-consultants): For independent regulatory and QA consultants: audit-ready client deliverables, with clients reviewing for free. - [For quality and regulatory teams](https://traceabledocs.com//solutions/quality-and-regulatory): Document control and audit-ready evidence. - [For systems engineers](https://traceabledocs.com//solutions/systems-engineers): Requirements decomposition and traceability across a system. - [For defence programs](https://traceabledocs.com//solutions/defence): What ISO 9001, AS9100D, MIL-STD-882E, DO-178C and ISO/IEC/IEEE 15288 expect of requirements, safety and documentation, and how Traceable keeps the evidence. - [FDA 21 CFR Part 11](https://traceabledocs.com//21-cfr-part-11): What Part 11 asks of electronic records and signatures, and how Traceable meets it, requirement by requirement. - [Compare](https://traceabledocs.com//compare): How Traceable compares with the established requirements tools. - [Jama Connect alternative](https://traceabledocs.com//compare/jama-alternative): Traceable compared with Jama Connect, for small and mid-size regulated teams. - [IBM DOORS alternative](https://traceabledocs.com//compare/ibm-doors-alternative): Traceable compared with IBM DOORS and DOORS Next. - [Polarion alternative](https://traceabledocs.com//compare/polarion-alternative): Traceable compared with Siemens Polarion. - [codebeamer alternative](https://traceabledocs.com//compare/codebeamer-alternative): Traceable compared with PTC codebeamer. - [Confluence for requirements](https://traceabledocs.com//compare/confluence-for-requirements): Where Confluence falls short as a requirements tool. - [Helix ALM alternative](https://traceabledocs.com//compare/helix-alm-alternative): Traceable compared with Perforce Helix ALM. - [Visure alternative](https://traceabledocs.com//compare/visure-alternative): Traceable compared with Visure Requirements. - [Word and SharePoint](https://traceabledocs.com//compare/word-and-sharepoint): What a team retires when it moves its design documents off Word, SharePoint and a separate e-signature tool. - [Requirements management in Excel](https://traceabledocs.com//compare/requirements-management-in-excel): When a spreadsheet stops being enough, and what breaks first. - [Templates](https://traceabledocs.com//templates): Free templates for regulated product teams. - [RTM template](https://traceabledocs.com//templates/requirements-traceability-matrix): A free requirements traceability matrix template in Excel and CSV, with a worked example. - [IEC 62304 checklist](https://traceabledocs.com//templates/iec-62304-checklist): A free checklist of the key IEC 62304 life-cycle deliverables and activities, scaled to your software safety class. ## Guides - [Design changes after launch: how to scope validation without starting over](https://traceabledocs.com//blog/design-changes-after-launch): Find what a post-launch change really touches, re-verify that, and record why the rest still stands. Published 2026-10-09. - [PMA readiness: closing DHF gaps before the audit](https://traceabledocs.com//blog/pma-readiness): The design history gaps inspectors find first, and how to close them before a premarket approval. Published 2026-10-09. - [DHF remediation for scaling medtechs](https://traceabledocs.com//blog/dhf-remediation): How to bring an incomplete design history file back to a defensible state, and keep it there. Published 2026-10-09. - [Using AI in a validated documentation process](https://traceabledocs.com//blog/ai-validated-documentation): How to let your team use AI on controlled documents without losing control of them. Published 2026-10-09. - [What is requirements management?](https://traceabledocs.com//blog/what-is-requirements-management): What it is, why it matters, the core process, and the role of traceability. Published 2026-09-01. - [IEC 62304: a practical guide](https://traceabledocs.com//blog/iec-62304-guide): Software safety classes, key deliverables, and the role of traceability. Published 2026-09-01. - [Medical device software development](https://traceabledocs.com//blog/medical-device-software-development): Safety classification, life-cycle activities, and the traceability that ties them together. Published 2026-09-01. - [ISO 13485 document control](https://traceabledocs.com//blog/iso-13485-document-control): What clauses 4.2.4 and 4.2.5 expect, and how to meet them without the manual overhead. Published 2026-09-01. - [ISO 14971 risk management](https://traceabledocs.com//blog/iso-14971-risk-management): The risk process, and why risk traceability is the part that breaks. Published 2026-09-01. - [Design history file (DHF)](https://traceabledocs.com//blog/design-history-file): What a DHF contains under the QMSR, how it relates to the medical device file, and how to keep it audit-ready. Published 2026-09-01. - [Document control for medical devices](https://traceabledocs.com//blog/document-control-medical-devices): Controlled documents in an ISO 13485 quality system, produced as a by-product of work. Published 2026-09-01. - [Traceability matrix for medical devices](https://traceabledocs.com//blog/traceability-matrix-medical-devices): From user needs to verification, and how to keep the matrix honest between audits. Published 2026-09-01. - [How to write good requirements](https://traceabledocs.com//blog/how-to-write-good-requirements): The characteristics of a good requirement, the pitfalls, and how to keep them traceable. Published 2026-09-01. - [Functional vs non-functional requirements](https://traceabledocs.com//blog/functional-vs-non-functional-requirements): What the product does vs how well it does it, with examples. Published 2026-09-01. - [Verification vs validation](https://traceabledocs.com//blog/verification-vs-validation): Building it right vs building the right thing, and why both trace to requirements. Published 2026-09-01. - [How to create a requirements traceability matrix](https://traceabledocs.com//blog/how-to-create-a-requirements-traceability-matrix): Six steps to a working RTM, and how to keep it current. Published 2026-09-01. ## Optional - [Legal documents](https://traceabledocs.com//legal): Mutual NDA, end-user licence agreement, privacy policy. - [Full documentation as one file](https://traceabledocs.com//llms-full.txt): every documentation article, concatenated.