Medical devices
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.
The problem
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.
80%
of critical know-how stays informal, held by a few key people.
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.
Our solutions
Capture know-how, secure compliance.
Three complementary levers, from ready-to-use content to field consulting.
Academy
Ready-to-deploy modules on quality, traceability and good manufacturing practices for your teams.
Explore the catalog → PlatformLearning Suite
Auditable certificates and audit-ready traceability to prove qualification to notified bodies.
See the platform → ConsultingConsulting
Field assessment, reduced operator variability and a more reliable DHR, with the method transferred. From €5k.
Request an assessment →Our results
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."
Request an assessment.
A Sinfony expert reviews your CAPAs, your traceability and your critical actions with your teams.