Medical Human Factors AG

Human factors research for medical devices and combination products; formative and validation studies, study design, ethics approval, execution, recruitment, analysis and reporting.

Use-related risk management for the product life cycle; risk planning, task analysis, human-error methods, risk assessment using FTA and FMEA, and updates with HF, clinical and post-market data.

Creation, development and post-market changes of instructions for use (IFU) for product instructions related to human factors and risk management.

Regulatory support for manufacturers; support with submissions, HF summary reports, pre-meeting packages, FDA Type-C and EU scientific advice meetings, and responses to regulator questions.