Your change-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 7
Agent 7
Your change-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 7Built on request
Turn whatever starts your change into ECO drafts and quotes, then automate 30+ actions
Let’s build your agent. Tell us about your current process and requirements.
About your change-to-ECO & Quote Agent
Whatever starts a change at your company, a custom AI agent could turn it into a draft ECO and a quote, for your team to review.
We build custom AI agents around each client's own process. The other agents in our Change Control Agent Suite each start from a common trigger: a BOM change, a customer request, an updated drawing, a supplier notice, a quality issue, a regulatory change. Many companies have a change that doesn't fit those six, or one that starts from their own forms and systems. This page is about that one. The suite's 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 →
Changes we hear about
Some examples of what else can start a change at a medical device maker or contract manufacturer:
- A cost reduction or a value-engineering idea.
- A second source for a part, or a supplier move.
- A manufacturing process change: new equipment, a new method, a new line.
- A site transfer, or moving work to or from a contract manufacturer.
- A test or inspection failure, or a trend in your own data.
- A software or firmware update to the device.
- An internal request form that doesn't match any of the above.
Each one ends in the same place: a controlled change, with its impact understood, its cost known and the right people deciding. What differs is where it starts and what has to be read first.
Why it matters under the QMSR
ISO 13485:2016 §4.1.4 asks you to evaluate changes to your processes for their impact on the quality management system and on the devices you make, and to control them. Design changes fall under §7.3.9, and a changed production process may need revalidation under §7.5.6. Since FDA's Quality Management System Regulation took effect on 2 February 2026, 21 CFR Part 820 incorporates ISO 13485 by reference, so the same expectations apply whatever started the change.
What the agent would do
The same four steps as every agent in the suite, applied to your trigger:
AI reads · coded rules check
Read your input
AI reads whatever starts your change: a form, an email, a report, a data export. Coded rules (fixed logic, not AI) then check what it found, and each item is designed to point back to where it came from. Anything missing or unclear is designed to be listed as a question rather than filled in.
AI agent · plans, checks, drafts, prices
Draft the ECO and the quote
The AI agent plans what the change needs, checks your files and drafts what the other agents draft: where it's used, stock and orders with suggested dispositions, approved suppliers, open ECOs on the same parts, the seven regulatory checks (significance, FDA filing, risk, testing, process / labeling / device ID, documents and training), and the cost impact and quote.
People · review, decide, send
People review, decide and send
The draft goes to the people your process names. 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 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 input and files it is given, and AI can misread an input, which is why people review every draft.
The checks, and where they come from
| Check | Requirement |
|---|---|
| Evaluate a process change for its impact on the QMS and the devices | ISO 13485 §4.1.4 (via 21 CFR 820.10) |
| Design changes: significance, review, verification or validation | ISO 13485 §7.3.9 |
| Does a changed process need revalidation? | ISO 13485 §7.5.6 |
| Does the change need a new 510(k)? PMA supplement? | 21 CFR 807.81(a)(3); 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. The decisions stay with your team.
What your team would get
- A draft ECO for each change, with the impact found in your files, the findings and the regulatory questions answered or left open, for your team to check and complete.
- A cost impact and, where a customer pays, a quote.
- A record of the change: what started it, what it affects, and who decided.
How we'd build yours
This is the agent where your process matters most, because we start from your trigger, not ours:
- 01
Discovery
we learn what starts your changes, how they're handled today and where the time goes, with the people who do the work.
- 02
Proof of concept
a working version on a few of your real cases, so you can judge the output for yourself.
- 03
Build and integration
connected to the systems you choose, such as your ERP, PLM, quality system or forms, 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 →
Our change process is unusual. Can it still work?
Often the unusual part is only the start: the form, the system or the people. The steps after it are the same regulated steps every manufacturer follows. Discovery is where we find out whether an agent is a good fit, and we'll tell you if it isn't.
Could one agent handle several triggers?
It can be built to, where they share a process. Some companies start with one trigger and add others once the first is working.
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. Nothing on this page is legal or regulatory advice.