# ISO 13485: your compliance depends on mastery of the action.

In medical devices, ISO 13485 compliance is proven record by record: a complete Device History Record, flawless traceability, correct marking, effective CAPAs. All of it rests on critical know-how held by your operators and your quality teams. Sinfony captures these actions so mastery stays in the company, whatever the departures and ramp-ups.

![Stylized medical device production line, symbolizing ISO 13485 compliance.](/assets/img/secteurs-dispositifs-medicaux/hero-dispositifs-medicaux-iso13485.webp)

## Traceability is only as good as execution.

Your ISO 13485 quality system is in place. But an incomplete DHR, a traceability gap or non-conforming marking always come from the same place: an action performed differently from one operator to the next. CAPAs then pile up on human causes that documentation alone doesn't fix.

up to 50%

variability between operators on the same critical manufacturing or control action.

Sinfony field observation

80%

of critical know-how stays informal, held by a few key people.

Sinfony field observation

### ISO 13485

Embed QMS requirements in real practice, not just in the procedures.

### DHR

Make Device History Record entries reliable as production unfolds.

### CAPA

Tackle the human root cause to reduce recurring CAPAs.

### Traceability & marking

Standardize identification and marking actions across the whole flow.

## Capture know-how, secure compliance.

Three complementary levers, from ready-to-use content to field consulting.

[Training

### Academy

Ready-to-deploy modules on quality, traceability and good manufacturing practices for your teams.

Explore the catalog →](/en/academy/) [Platform

### Learning Suite

Auditable certificates and audit-ready traceability to prove qualification to notified bodies.

See the platform →](/en/learning-suite/) [Consulting

### Consulting

Field assessment, reduced operator variability and a more reliable DHR, with the method transferred. From €5k.

Request an assessment →](/en/consulting/)

## The proof, in numbers.

What medical-device manufacturers see once their actions are captured.

−95%

training-related errors

−90%

documentation / training gap

−50%

onboarding effort

20,000

certificates that stand up to auditors

> "I've worked here for six years, and no one had ever explained my job to me like that."

GSK

## Request an assessment.

A Sinfony expert reviews your CAPAs, your traceability and your critical actions with your teams.