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Human Factors Engineering and Usability Engineering in the Medical Device Industry

 
  August 29, 2017  
     
 
CfPA-The Center for Professional Advancement, Online Live
October 16, 2017 at 11:00 a.m. – 12:30 p.m. (ET)


Who Should Attend?
This online training is designed for professionals in the Medical Device Industry. It will be especially valuable to:
  • Novice to mid-career professionals 
  • Quality or Regulatory Professionals 
  • Medical device/combination product research and design professionals
  • Quality engineers
  • Graduates of Human Factors Psychology, Computer Science and Engineering 
     programs 

Course Description
This 90-minute, accredited training course will explain the definition of a medical device and differentiate it from a drug. The FDA device classifications which are based on the level of control necessary to ensure safety and effectiveness and reduce risk or potential harm to the user will be addressed. In addition, a thorough explanation of the US FDA regulations and pathways for devices and combination products to achieve clearance/approval will be discussed. The course will include a description of ISO 62366:2015 and ISO14971:2007/2010 and the utility of these standards and relevant guidance documents useful to product development and when they should be implemented.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Suzan Olson, PhD, MHS, RN

Suzan Olson, PhD, MHS, RN works closely with manufacturers and engineers applying user experience (UX) design with research to ensure safety and effectiveness of medical devices, combination products and healthcare websites and applications. For over a decade, Dr. Olson has been responsible for planning, execution and documentation of clinical trials and human factors studies in medicinals and devices across North America, Europe, Asia, and Australia.

Dr. Olson received her PhD in psychology from Wichita State University. She has master’s and bachelor’s degrees in Health Care Administration and practiced acute care nursing for 25 years in both civilian and military environments. She holds professional certificates in Executive Leadership through University Alliance at the University of Notre Dame’s Mendoza College of Business and Master Black Belt in Lean Six Sigma from Villanova University. She is a Certified Usability Analyst (Human Factors International).  

Dr. Olson has numerous publications in the popular press and peer-reviewed journals including book chapters on topics of safety and the culture of healthcare organizations, ergonomics of air ambulance and fixed wing aircraft and nursing informatics.

Dr. Olson is Principal of MDH Human Factors, LLC, a woman-owned contract research firm based in Austin, TX that provides outsourced human factors engineering/usability engineering (HFE/UE) and other contract services to pharmaceutical and device companies and teaches online at UC-San Diego Extension on topics of statistics, good clinical practice and regulations of drugs and devices.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
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