Regulation-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 6
Agent 6
Regulation-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 6Built on request
Turn new regulations into ECO drafts and quotes, then automate 30+ actions
Let’s build this agent. Tell us about your current process and requirements.
About the Regulation-to-ECO & Quote Agent
What a custom AI agent could do with a new or revised standard or regulation: assess what it means for your products and draft the ECOs and quotes, 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 starts from a regulatory change, such as a new edition of a standard, a new labeling rule or a new regulation, and prepares the product changes it leads to. 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 regulatory change rarely arrives as a list of what to change. Someone in Regulatory Affairs reads the new text, compares it with the old, and works out which products, labels, instructions for use, test reports and technical files it reaches. Each affected product then needs its own change, with its own cost and timeline, often across many product families at once, so one regulatory change can reach a large number of documents.
Why it matters under the QMSR
ISO 13485:2016 asks you to determine the regulatory requirements that apply to each product (§7.2.1) and lists new or revised regulatory requirements as an input to management review (§5.6.2). Since FDA's Quality Management System Regulation took effect on 2 February 2026, 21 CFR Part 820 incorporates ISO 13485 by reference. The QMSR transition itself is an example of the kind of change this agent is about: procedures, records and labeling controls had to be looked at again against the new structure.
Standards change too. When FDA recognizes a new edition of a consensus standard it may set a transition period, after which declarations of conformity to the older edition are no longer accepted for new submissions. FDA's Recognized Consensus Standards database lists each standard's recognition and transition dates.
What the agent would do
The same four steps as every agent in the suite, applied to a regulatory change:
AI reads · coded rules check
Assess the regulatory impact
AI reads the new text and the version it replaces, lists what changed, and matches each change to your products, labels and documents. Coded rules (fixed logic, not AI) then check what it found, and each match is designed to point back to the clause it came from. Anything that needs interpretation, such as whether a clause applies to a device class, is designed to be listed as a question for Regulatory Affairs rather than answered.
AI agent · plans, checks, drafts, prices
Draft the ECOs and the quotes
The AI agent plans what each affected product needs, checks your files and drafts:
- Products affectedthe devices and product families in your files that the change reaches, and the documents in each (labels, instructions for use, test reports, technical files).
- The gap listwhat each product does today against what the change requires, item by item.
- One ECO per product or family, with the label, document, test or design changes it needs.
- Stock and orderslabeled stock and open orders that the change affects, with a suggested disposition and the quantity it rests on.
- 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 quoterelabeling, retesting, document updates and design work, rolled into a cost impact and, for contract manufacturers, quotes for the customers whose products are affected.
People · review, decide, send
People review, decide and send
The drafts go to Regulatory Affairs, Quality and Engineering. Your team interprets the regulation and 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 clause, 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 texts and files it is given, and AI can misread a regulation, which is why people review every draft.
The checks, and where they come from
| Check | Requirement |
|---|---|
| Determine the regulatory requirements that apply to each product | ISO 13485 §7.2.1 (via 21 CFR 820.10) |
| New or revised requirements reviewed by management | ISO 13485 §5.6.2 |
| Declarations of conformity to the current edition of recognized standards | FDA Recognized Consensus Standards database |
| Does a resulting design 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. Interpreting the regulation, and deciding what to file, stays your regulatory team's call.
What your team would get
- A summary of what changed in the regulation or standard, clause by clause, for Regulatory Affairs to confirm.
- A gap list per affected product, and a draft ECO for each, for your team to check and complete.
- A cost impact across the products affected, and quotes for customers where they pay for the change.
- A record of the assessment: what changed, what it reaches, and who decided.
How we'd build yours
Every company tracks regulatory change its own way: which markets and standards matter, where labels and technical files live, how ECOs are numbered and routed. So we don't sell this agent off the shelf. We start from your process:
- 01
Discovery
we map how regulatory changes are assessed today, with the people who assess them.
- 02
Proof of concept
a working version on one or two real changes you've handled, so you can compare its output with your own assessment.
- 03
Build and integration
connected to the systems you choose, such as your document control, labeling system, PLM or ERP, and tested against your cases.
- 04
Go-live and tuning
your team trained, results monitored, rules adjusted as your markets change.
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 →
Does it monitor regulators for new changes?
It can start from a change your team forwards, or from a regulatory news source you already follow. Which one depends on your setup; we'd settle it in discovery.
Does it interpret the regulation for us?
No. It is designed to lay out what changed and where it appears to apply, and to list the questions that need a regulatory judgement. The judgement stays with your people.
Which regulations could it cover?
Whichever matter to your products: FDA rules, recognized standards, and regulations in your other markets. We'd agree the list in discovery.
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.