Description
Risk Analysis Documentation (ISO 14971)
Comprehensive risk management documentation meeting ISO 14971:2019 requirements — essential quality system documentation for FDA, EU MDR/IVDR, and global regulatory submissions. We build your risk management file from the risk management plan through analysis, evaluation, and control to the final risk management report, whether you are developing a new device, making design changes, or updating post-market risk.
Service Details
| Turnaround | Standard: 6–10 weeks, depending on device complexity |
| Standard | ISO 14971:2019 – Risk management for medical devices |
| What you receive | A complete risk management file: plan, analysis, evaluation, control, and report |
| Best for | New device development, design changes, post-market risk updates, and CAPA integration |
Regulatory Framework
- ISO 14971:2019 – Risk management for medical devices
- ISO/TR 24971:2020 – Application guidance
- EU MDR Annex I – General Safety and Performance Requirements
- FDA 21 CFR 820 (QMSR) – Design controls
- IEC 62304 – Software risk management
Risk Documentation Package
- Risk Management Plan – Scope, responsibilities, criteria
- Risk Analysis – Hazard identification, risk estimation
- Risk Evaluation – Acceptability determination
- Risk Control – Mitigation measures, verification
- Risk Management Report – Overall residual risk, conclusions
- Risk Management File – Complete documentation package
Analysis Methods
- FMEA (Failure Mode and Effects Analysis)
- FTA (Fault Tree Analysis)
- HAZOP (Hazard and Operability Study)
- Use-related risk analysis
Applications
- New device development
- Design changes
- Post-market risk updates
- CAPA integration
How It Works
- Send us your device information and any existing design, risk, or post-market documentation
- We prepare the risk management plan and carry out the risk analysis, evaluation, and control documentation
- You review the drafts and we revise based on your feedback
- You receive the final risk management report and complete risk management file
Which Service Do You Need?
This service produces the risk management file. If you also need the human factors side of use-related risk — use specification, formative and summative evaluation reports, and the human factors engineering file — see Usability/Human Factors Study Report.
Frequently Asked Questions
Which standards and regulations does it address?
ISO 14971:2019, ISO/TR 24971:2020 application guidance, EU MDR Annex I General Safety and Performance Requirements, FDA 21 CFR 820 (QMSR) design controls, and IEC 62304 software risk management.
Which analysis methods do you use?
FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis), HAZOP (Hazard and Operability Study), and use-related risk analysis.
Can you update risk documentation for an existing device?
Yes. Beyond new device development, applications include design changes, post-market risk updates, and CAPA integration.
How long does it take?
The standard timeline is 6–10 weeks, depending on device complexity.
Get started: add this service to your cart, or email co*****@*******se.com with your device information and any existing risk documentation to discuss scope.
