Integration of Human Factors into Medical Device Design: FDA and European Commission

Description

Integration of Human Factors into Medical Device Design: FDA and European Commission 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  • Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)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  • Draft Guidance for Human Factors and Combination Products (TBD for release from the FDA)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 brings together:

  • Compliance
  • Regulatory
  • Project Managers
  • Product Managers
  • Device Design Engineers
  • Quality Assurance

Future Events

Integration of Human Factors into Medical Device Design: FDA and European Commission 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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