ISO 13485 Certification
Certification for organizations that want to demonstrate a medical-device quality management system.
What it is
A quality-management standard for organizations involved in the medical-device life cycle.
Who commonly needs it
Medical-device manufacturers, suppliers, service providers, sterilization providers and device-software organizations.
Certification process
Calculate, confirm the scope and quotation, then complete the required audit stages with the selected provider.
Typical audit factors
- Device scope and risk
- Sterile processes
- Regulatory markets
- Sites and outsourced processes
Common questions
Is ISO 13485 available as accredited certification?
Yes, subject to an independent certification body having the applicable accreditation scope. A clearly labelled non-accredited private route may also be available.
Can the audit be remote?
Sometimes. The provider confirms whether remote, hybrid or on-site delivery is suitable for the scope and evidence.
Is the calculator price final?
No. The final quotation is issued after the scope, duration, availability and delivery method are reviewed.