Drawing-to-ECO & Quote Agent
Built on requestEvery change starts somewhere. It should end in a clean ECO and a quote.
Pick where your change starts
Agent 3
Agent 3
Drawing-to-ECO & Quote Agent
- AI reads the input, then coded rules (fixed logic, not AI) check what it found, with sources.
- Plans what each change needs, checks your files for it, drafts the ECO and prices the quote.Read-only: it never changes your files, and works within set limits.Cited: every finding names the file and row it came from.Reviewed: it goes over its own work before handing it to you.
- People review the draft and make and record every decision. Routed to Quality, Engineering, and others as appropriate.
- Switch on only the follow-up actions you need: emails, tasks, and updates in your other systems such as SAP, Oracle, Jira or Teams. Not in this demo: we’ll discuss your follow-up actions in a discovery call. Once switched on, nothing changes in your systems without your approval.
The steps above combine:AUTOMATIONAIHUMAN-IN-THE-LOOP
Automate any of 30+ follow-up actions
switch on what you needNot in this demo: we’ll discuss your follow-up actions in a discovery call.
ECO initiation
Design engineering
Document control
Manufacturing eng.
Purchasing & supply
QA/RA
Project leadership
Agent 3Built on request
Turn drawing revisions into ECO drafts and quotes, then automate 30+ actions
Let’s build this agent. Tell us about your current process and requirements.
About the Drawing-to-ECO & Quote Agent
What a custom AI agent could do with an updated drawing or specification: compare it with the current one, then draft the ECO and a quote, for your team to review.
We build custom AI agents around each client's own process. This page shows one we would build for medical device makers and their manufacturing partners: an agent that takes an updated drawing or specification, finds what changed against the current one, and does the groundwork that follows. It is part of our Change Control Agent Suite. Its first agent, the BOM-to-ECO & Quote Agent, is live, and you can try it with sample files or your own.
See the approach working: try the live BOM-to-ECO & Quote Agent →
The manual work today
When a drawing or specification changes, someone usually compares the old and new versions side by side, looking for every changed dimension, tolerance, material, finish and note. Small changes are the easy ones to miss: a tolerance tightened in one view, a note that now calls out a different standard. Each change then has to be traced to what it affects: the BOM, the routings, inspection plans and first-article requirements, fixtures and tooling, supplier quotes, and the device's design and risk files.
Why it matters under the QMSR
ISO 13485:2016 §7.3.9 asks you to determine the significance of a design change, review it, verify or validate it as appropriate, and approve it before it is implemented. The review has to include the change's effect on constituent parts, on product in process or already delivered, and on the inputs and outputs of risk management. Since FDA's Quality Management System Regulation took effect on 2 February 2026, 21 CFR Part 820 incorporates ISO 13485 by reference.
Routing a design change through the wrong process is a finding in its own right. In a 2024 warning letter, FDA noted that a manufacturer's "multiple design changes were instead processed using Manufacturing Deviation", and that "the documentation does not include verification/validation results to ensure no adverse effect on the device."
What the agent would do
The same four steps as every agent in the suite, applied to a drawing change:
AI reads · coded rules check
Compare the drawings
AI reads the current and the updated drawing or specification and lists what differs: dimensions, tolerances, materials, finishes, notes, referenced standards and the title block. Coded rules (fixed logic, not AI) then check what it found, and each difference is designed to point to where it sits on both drawings. Anything it can't read with confidence, such as a smudged dimension or a view it can't match, is designed to be listed for a person to check rather than skipped.
AI agent · plans, checks, drafts, prices
Draft the ECO and the quote
The AI agent plans what each difference needs, checks your files and drafts:
- Where it's usedthe BOMs, assemblies and finished devices in your files that use the part.
- Manufacturing impactroutings, inspection plans, first-article inspection, fixtures and tooling that the difference may touch.
- Stock and orderson hand, work in process and open orders made to the current drawing, with a suggested disposition for each (use as is, rework, scrap, use until a cut-off) and the quantity it rests on.
- Open changesother open ECOs on the same part in your ECO log, to help keep two changes from colliding.
- Regulatory questionsthe same seven checks as our live agent (significance, FDA filing, risk, testing, process / labeling / device ID, documents and training), each with the requirement it comes from.
- Cost and quotematerial, tooling and fixture changes, rework or scrap, and verification work, rolled into a quote for the change.
People · review, decide, send
People review, decide and send
The draft goes to Engineering, Quality and Manufacturing. Your team makes and records every decision; the agent prepares the work and decides nothing.
Automation · optional
Follow-up actions, if you want them
Emails, tasks and updates in systems such as SAP, Oracle, Jira or Teams, each switched on separately and designed so nothing changes in your systems without your approval.
Each finding is designed to name the file and row, or the drawing and view, it came from, and a check whose file wasn't provided shows as Not checked, not as a clean result. The output is only as complete as the drawings and files it is given, and AI can misread a drawing, which is why people review every draft.
The checks, and where they come from
| Check | Requirement |
|---|---|
| Significance, review, verification or validation, approval before implementation | ISO 13485 §7.3.9 (via 21 CFR 820.10) |
| Effect on parts, product in process and delivered product, and risk management | ISO 13485 §7.3.9 |
| Does a changed process need revalidation? | ISO 13485 §7.5.6 |
| Does the change need a new 510(k)? | 21 CFR 807.81(a)(3); FDA guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device" (2017) |
| PMA devices: is a supplement needed? | 21 CFR 814.39 |
| Labeling and packaging affected? New UDI device identifier needed? | 21 CFR 820.45; 21 CFR 830.50 |
| Units already in the field | 21 CFR Part 806 |
Each requirement, with its source, is on our QMSR mapping page. The agent raises these questions and shows its working. Whether a change needs a filing stays your regulatory team's call.
What your team would get
- A list of differences between the two drawings, each located on both, for your engineers to confirm.
- A draft ECO: the affected parts, assemblies and devices found in your files, the manufacturing impact, the findings and the regulatory questions answered or left open, for your team to check and complete.
- A cost impact and a quote for the change.
- A record of the design change review: what changed, what it affects, and who decided.
How we'd build yours
Every company handles drawing changes its own way: CAD and PLM tools, drawing standards, how ECOs are numbered and routed, what goes in the design history file. So we don't sell this agent off the shelf. We start from your process:
- 01
Discovery
we map how drawing changes are handled today, with the people who handle them.
- 02
Proof of concept
a working version on a few of your real drawing changes, so you can judge the output for yourself.
- 03
Build and integration
connected to the systems you choose, such as your PLM, ERP or document control, and tested against your cases.
- 04
Go-live and tuning
your team trained, results monitored, rules adjusted as your process changes.
The live BOM-to-ECO & Quote Agent shows the approach working today, on the same engine this agent would use.
Questions buyers ask
Is this a product we can buy?
Not off the shelf. We build it for you, around your process, your customers' requirements and your systems (ERP, PLM, quality). The best way to start is with a 2-week pilot around your needs. Book a Discovery Call →
Which drawing formats could it read?
That depends on what you use. PDF drawings are the common case; native CAD or PLM data can be an option where your systems allow it. We'd settle it in discovery, on your real drawings.
Will it catch every difference?
No tool should promise that. It is designed to list each difference it finds with its location on both drawings, and to flag what it couldn't read, so your engineers confirm the list rather than build it from scratch.
Is it validated?
Not out of the box. If your team uses an agent like this as part of your quality system, ISO 13485 §4.1.6 asks you to validate that software for its intended use, in proportion to the risk. We design our builds with that in mind and can talk through what your validation would need.
Talk to us about an agent built to your process.
Book a Discovery CallDisclaimer: This page describes an example of an agent we would build to a client's process: how it is designed to work, not a product or a guaranteed result. Any agent we build is advisory and not a validated system. AI can make mistakes, results depend on the data it is given, and the regulatory checks raise questions without deciding them. Your team reviews the output and makes and records every decision. Time figures are estimates, not measurements. Nothing on this page is legal or regulatory advice.