Risk Analysis
Our Risk Management starts with being ISO 14971 compliant. We perform risk analysis, risk evaluation, risk mitigations and residual risk assessment. Conducting activities from hazard analysis through FMEA, we ensure your device meets its requirements.
We believe that risk analysis and risk management is crucial to both medical and consumer devices. Our ability to identify project, product and consumer risks helps alleviate costly oversights early in the design process.
We practice early identification of hazard controls using our risk analysis system in order to build robustness and traceability into your project. Our risk analysis process is compatible with EN 60601 standards.
Case Studies
