Supplier-Notice-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 4
Agent 4
Supplier-Notice-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 4Built on request
Turn PCNs and end-of-life notices into ECO drafts and quotes, then automate 30+ actions
Let’s build this agent. Tell us about your current process and requirements.
About the Supplier-Notice-to-ECO & Quote Agent
What a custom AI agent could do with a supplier's PCN or end-of-life notice: turn it into a draft ECO and a customer 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 contract manufacturers: an agent that takes a supplier's product change notice (PCN) or end-of-life notice and does the groundwork your team does by hand today. 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
A notice usually arrives as a PDF or an email. Before anyone can decide anything, someone has to work out which of your parts it names, which assemblies and devices use them, how much stock and how many open orders are affected, whether an approved alternate exists, and what the change means for the device and its filings. That work typically spans Purchasing, Engineering and Quality.
Notices are not always complete, and sometimes they are never sent. Missed changes have consequences: in a 2018 warning letter, FDA cited a device maker whose supplier changed a process "without regulatory review" because the supplier "failed to notify" it.
Why it matters under the QMSR
Under ISO 13485:2016 §7.4.2, your purchasing agreements should, where applicable, require suppliers to tell you about changes before they make them. Under §7.4.3, once you know about a change to purchased product, you must determine whether it affects your product realization process or the medical device. Since FDA's Quality Management System Regulation took effect on 2 February 2026, 21 CFR Part 820 incorporates ISO 13485 by reference, so that determination is an FDA expectation as well.
What the agent would do
The same four steps as every agent in the suite, applied to a supplier notice:
AI reads · coded rules check
Read the notice
AI pulls out the supplier part numbers, the type of change, the dates (last-time buy, last ship, effective date or lot) and the supplier's own assessment. Coded rules (fixed logic, not AI) then check what it found, and each field is designed to point back to where it came from in the notice. Anything it can't find in the notice, such as a lot cut-off, is designed to be listed as missing rather than filled in.
AI agent · plans, checks, drafts, prices
Draft the ECO and the quote
The AI agent plans what each affected part needs, checks your files and drafts:
- Where it's usedthe BOMs, assemblies and finished devices in your files that contain the part.
- Stock and orderson hand, on order and open POs, with a suggested disposition for each (use until consumed, last-time buy, return, scrap, rework) and the quantity it rests on.
- Alternateswhether a replacement is already on your approved supplier list, or needs qualifying first.
- 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 quotethe cost of a last-time buy or the new part, scrap and rework, and requalification work, rolled into a customer quote for the change.
People · review, decide, send
People review, decide and send
The draft goes to Quality, Engineering and Purchasing. 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 files and notices it is given, and AI can misread a notice, which is why people review every draft.
The checks, and where they come from
| Check | Requirement |
|---|---|
| Act on the supplier's change notice | ISO 13485 §7.4.2, §7.4.3 (via 21 CFR 820.10) |
| Alternate parts from approved suppliers only | ISO 13485 §7.4.1 |
| 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? | 21 CFR 820.45 |
| New UDI device identifier needed? | 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 draft ECO: the affected parts, assemblies and devices 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 a customer quote for the change, especially useful to contract manufacturers who re-quote the OEMs they build for.
- A record of the §7.4.3 determination: what changed, what it affects, and who decided.
How we'd build yours
No two companies handle supplier notices the same way: who owns them, where stock and supplier data live, how ECOs are numbered and routed, which notices matter. So we don't sell this agent off the shelf. We start from your process:
- 01
Discovery
we map how notices are handled today, with the people who handle them.
- 02
Proof of concept
a working version on a few of your real notices and files, so you can judge the output for yourself.
- 03
Build and integration
connected to the systems you choose, such as your ERP, PLM, document control or an existing PCN service, 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 →
Would it watch supplier portals for new notices?
It can start from notices you forward or upload, or, if you already use a PCN-tracking service, from that service's feed. Which one depends on your setup; we'd settle it in discovery.
What if a notice is incomplete?
The agent lists what's missing (affected lots, dates, the supplier's evidence) and can draft the request back to the supplier. It is designed to flag gaps rather than fill them.
Can it handle many notices at once?
It can be built to: each notice gets its own draft, and a part named in more than one notice is flagged across them.
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.