Clinical safety ISO 13485
ISO 13485
The quality management standard for medical devices.
- The backbone of EU and UK device regulation.
- In Qyro, the whole system arrives configured to your company.
- Documents in your library
- 93
- Sections of the standard
- 5
What's in your library.
Qyro Library follows the standard's own structure.
Tailored, not templated.
Five folders, in the order of the standard, each document shaped by your answers.
Your path to certification.
1Gap analysisWhere you stand
2ImplementationControls in place
3Internal auditChecked first
4Management reviewSigned off
5Stage 1 auditDocuments
6Stage 2 auditPractice
7SurveillanceEvery year
“Their support helped us successfully navigate ISO27001 and ISO13485 readiness, strengthen our medical device governance, and approach complex customer conversations with significantly greater confidence.”
Andrew Davies, Head of Product, Agyle