Industries · Medical devices
Medical device work instructions — controlled, trained and on record.
In medical device production, a deviation is never just a defect. REWO delivers the approved revision to every station, trains operators on exactly that version, and keeps the signed record your auditors expect.
Audit-ready for ISO 13485 · ISO 9001
The challenge
Why medical device lines are hard to keep compliant
Every change is controlled
A revised procedure needs review, approval and retraining before anyone works to it.
Training must be provable
Auditors ask which operators were trained on which revision, and when.
Controlled, automated cells
Complex steps in controlled environments are hard to explain on paper.
Lines move between sites
Transferring a validated process to another plant must not lose the method.
In practice
How medical device manufacturers use REWO
Controlled instructions at the station
Only the approved revision reaches the line; the previous one retires the moment the new one goes live.
Retraining after every change
A revised instruction is re-assigned, and a short assessment confirms it was understood.
Role-based training paths
Certify operators for a process or an area, with a validity you set.
Training records for audits
Show who was trained on which revision, when, and with what signature.
Inside your MES or QMS
Deliver instructions inside the system operators already use, or standalone by QR.
Audits
The record behind your audit
REWO doesn't certify your quality system — your QMS and your auditors do that. REWO gives you the record behind it: approved, versioned instructions, retraining tied to each change, and signed training records for every operator.
- ISO 13485
- ISO 9001
- Controlled documents
In production
Running on medical device lines today
REWO is in use at medical device manufacturers with highly automated, strictly controlled production.
FAQ
Questions, answered
- Does REWO make us ISO 13485 compliant?
- No software can. REWO gives you the evidence auditors ask for on controlled instructions and training: the approved revision, who was trained on it, and when they signed.
- Can our QMS stay the master?
- Yes. REWO can deliver documents your QMS controls, or be the controlled system for shop-floor instructions itself.
- What happens when a procedure changes?
- The new revision is approved, everyone who uses it is re-assigned, and the old version retires automatically.
- Can REWO run inside our MES?
- Yes. REWO connects through its REST API — Coloplast runs it inside its own MES.
See REWO on a medical device line
A live, 30-minute walkthrough built around one of your own instructions.