Know what's inside:
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 risks, 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 to reduce risks as far as possible
- 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 and summative usability testing to identify and resolve use-related risks
- Usability file compilation for technical documentation
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Ready to take your medical devices to the next level? Contact us today to learn how our comprehensive MedTech solutions can support your needs.