Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)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Draft Guidance for Human Factors and Combination Products (TBD for release from the FDA)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
Who should Attend
Compliance
Regulatory
Project Managers
Product Managers
Device Design Engineers
Quality Assurance
Past Events
Integration of Human Factors into Medical Device Design: FDA and European Commission 2016 - 21-22 Apr 2016, San Francisco, California, United States (58358)
Important
Please, check "Integration of Human Factors into Medical Device Design: FDA and European Commission" official website for possible changes, before making any traveling arrangements
