Analyze
Identify hazards, define harm and estimate risks with criteria that match your device.
ISO 14971
Risk management that connects hazards to controls and evidence
Build risk files that match your device and use cases, keep traceability through design and verification, and show auditors a clear story from hazard to residual risk.
Right level of detail
Files scaled to device class and risk profile
Files scaled to device class and risk profile
Traceability
Hazards to controls and verification mapped
Hazards to controls and verification mapped
Audit ready
Evidence organized for quick sampling
Evidence organized for quick sampling
Aligned with markets
Links into ISO 13485, MDR and FDA QMSR
Links into ISO 13485, MDR and FDA QMSR
Scope
What we execute and what you receive
We create and integrate risk management so it drives design decisions and stands up to inspection.
Risk activities we run
- Risk management plan and file setup
- Hazard identification and risk analysis methods
- Severity and probability definitions suited to your device
- Risk evaluation criteria and acceptability matrix
- Risk controls selection and verification planning
- Software risk and cybersecurity linkages when applicable
- Usability and clinical considerations for risk
- Production and post production information process
- Change control and periodic risk review
Deliverables you bring to audit
- Risk management plan and procedures
- Hazard analysis with controls and residual risk
- Traceability to design inputs, verification and validation
- Risk benefit analysis where required
- Software and cybersecurity risk artifacts
- Usability risk summary and mitigations
- Production and post production data reviews
- Management review and CAPA linkages for risk topics
How it works
From hazard analysis to verified controls step by step
We align activities with your device and team so each hour builds evidence and clear traceability.
Control
Select controls, verify effectiveness and link to design inputs and tests.
Monitor
Collect production and post production data and update risk files with real feedback.
FAQ
Common questions
Do you integrate risk with design controls?
Yes. Risk drives inputs and verification and remains visible in technical documentation and records.
How do you size the effort for our device?
We adjust methods and depth based on class, novelty and intended use to keep the work practical and compliant.
Can you help with software and cybersecurity risk?
Yes. We include software risk per IEC 62304 and link cybersecurity controls into the risk file where applicable.
How often should we review risk after launch?
At minimum annually and whenever post production data indicates changes in frequency, severity or detection.
Ready to make risk your advantage?
Book a quick call to align deliverables and dates and set up a risk file that accelerates approvals.