Integration of Human Factors into Medical Device Design: FDA and European Commission 2016 is a seminar that covers topics such as:
- ANSI/AAMI HE75: 2009(R) 2013
- Defining Human Factors, Ergonomics, and Usability
- Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)
- IEC 62366-1:2015
- Draft Guidance for Human Factors and Combination Products (TBD for release from the FDA)
- Design Considerations for Devices Intended for Home Use, Guidance for Industry and Food and Drug Administration Staff (November 24, 2014)
- Human Factors Summative Testing
- Human Factors Formative Testing
- User Training
- Information for Use (IFU)/ Labelling
- Using Human Factors to Design Medical Devices, not just evaluate
- Creating and Maintaining a Usability History File
Integration of Human Factors into Medical Device Design: FDA and European Commission 2016 brings together:
- Compliance
- Regulatory
- Project Managers
- Product Managers
- Device Design Engineers
- Quality Assurance