AAMI - Human Factors for Medical Devices

  • 02 Mar - 04 Mar 2020
  • Hilton Cambridge City Centre
  • Cambridge / England

This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device.  The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on pharma.

A basic foundation for applying human factors will be set, with discussions on user models and task analysis; anatomy of use errors; and how task analysis forms the basis for planning human factors efforts. Course content will also include a review of human factors methodologies – contextual inquiry, heuristic evaluations, formative studies, and summative studies. Relevant human factors standards are discussed as well as human factors in the post-market arena. There are hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices. 

This course is designed for quality and design engineers; research and development managers; risk managers; personnel from marketing, regulatory affairs, quality assurance, clinical/medical affairs, and customer service; and government regulators who are new to the application of human factors to medical devices.

Benefits of Attending This Event

  • World renowned course being held locally
  • Opportunity to expand your organisations knowledge of quality systems regulations
  • Opportunity to discuss interpretations with other medical device manufacturers
  • Networking opportunity to bring multiple divisions of your organisation together locally
  • Siginificant cost and time savings

 

Course Highlights

  • Intensive 3 day program developed by the FDA and quality system experts
  • World class faculty
  • Introduction and Overview 
  • Case Study 1
  • Preliminary Analysis: Uses, Users, Use Environments, and User Interfaces
  • Preliminary Analysis: Analytical Approaches to Identifying Use Related Risks
  • Preliminary Analysis: Use Related Risks Part 2, Task Analysis and PCA
  • Preliminary Analysis: Analytical Methods, Empirical Methods
  • Formative Exercises and Reporting
  • Root Cause Analysis 
  • Risk Elimination and Reduction Standards 
  • Rosetta Stone
  • FDA - CDRH and CDER
  • Validation Exercises
  • Group Presentations


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Less than 5

€2495

Lunch included

2% fee with be added for CC transactions

 

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5 Plus Attendees

€2369

5% off

Lunch included

2% fee with be added for CC transactions

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10 Plus Attendees

€2245

10% off

Lunch included

2% fee with be added for CC transactions

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