Medical Devices
ISO 13485 — Medical Devices Quality Management
Prove your medical devices meet global safety standards.
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About this standard
ISO 13485 certification demonstrates that your organization designs, manufactures, and services medical devices with the rigorous quality controls required by regulators and healthcare buyers worldwide.
Benefits of certification
- Access to regulated medical device markets
- Stronger risk management across the product lifecycle
- Improved traceability of components and devices
- Confidence for regulators, distributors, and hospitals
Key requirements
- Design and development controls for medical devices
- Risk management process aligned with ISO 14971
- Device traceability and complaint handling procedures
- Regulatory compliance monitoring across target markets
Audit flow you'll go through
Every step is planned, executed, technically reviewed, and decided independently, in line with ISO/IEC 17021-1:2015.
- 1
Application & Quotation
Submit your application and scope; we review it and issue a certification quotation.
- 2
Stage 1 Audit
Document review and readiness assessment to confirm your management system is ready for Stage 2.
- 3
Stage 2 Audit
On-site audit evaluating implementation and effectiveness of your management system against the standard.
- 4
Technical Review & Decision
Findings are independently reviewed and a certification decision is made by a qualified committee.
- 5
Certificate Issued
Your certificate is issued and registered, valid for a 3-year cycle.
- 6
Surveillance Audit 1 & 2
Annual surveillance audits confirm continued conformity and improvement.
- 7
Recertification
A full audit before expiry renews your certificate for another 3-year cycle.
Ready to get certified for ISO 13485?
Start your certification application today. Our team will guide you through the entire ISO/IEC 17021-1 process.
Apply for CertificationRequest ISO 13485 certification
Submit your details and our team will start your application per ISO/IEC 17021-1.