Human factors engineering is essential when developing medical devices and combination products, leave it to us to help. We understand the regulations and the process, we know how to implement solutions that satisfy IEC 62366 and IEC 60601, we can help you with the following deliverables:
- Human Factors (HF) Plan and Report
- Creation of the Use Related Risk Analysis (URRA)
- Human Factors testing planning
- Human Factors testing
- Integration of Usability into Product Design
- HF Formative and Summative Plan, Protocols and Reports