Medical Devices
ISO 14971 — Medical Device Risk Management
Manage risk across the device lifecycle.
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About this standard
ISO 14971 specifies a process for identifying hazards and estimating and evaluating risks associated with medical devices throughout their lifecycle.
Benefits of certification
- Systematic device risk management
- Compliance with medical device regulations
- Improved patient safety
- Stronger regulatory submission quality
Key requirements
- Hazard identification and risk analysis
- Risk evaluation and control implementation
- Residual risk evaluation and benefit-risk analysis
- Risk management file and post-production monitoring
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 start your certification journey?
Apply online and our team will guide you through every step — from quotation to certificate issuance, fully aligned with ISO/IEC 17021-1.
Request ISO 14971 certification
Submit your details and our team will start your application per ISO/IEC 17021-1.