Risk Management and Usability
Integrated Risk Thinking for MDR Compliance
Effective risk management is not an isolated activity, it is a continuous process embedded in every phase of medical device development. We implement a risk-based approach, ensuring that all potential hazards, from design through post-market use, are identified, evaluated, and controlled early and iteratively.
Our methodology aligns with MDR Annex I and includes:
- Hazard identification across technical, clinical, and user interactions
- Risk analysis and evaluation using tools such as FMEA, FTA, and PHA
- Risk control measures linked to design verification
- Residual risk documentation for clinical evaluation and labeling
- Post-market surveillance integration to ensure real-world risk feedback
Human-Centered Usability Engineering
Meeting regulatory requirements for usability is not just about compliance, it's about ensuring safety, intuitive operation, and user acceptance in clinical environments. Our usability services focus on:
- User and environment analysis (clinical workflows, context of use)
- Use specification and task analysis
- Formative usability testing to identify and resolve use-related risks
- Human factors validation integrated into design verification
- Usability file compilation for technical documentation
Why It Matters
Adverse events and regulatory scrutiny are often caused by poor usability. Integrating usability and risk early reduces the likelihood of costly design iterations, clinical trial delays, and nonconformities during audits.
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