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Human Factors and Medical Devices

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Overview / Abstract:

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

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.


Apr 03, 2018


Education (Higher Ed)


Live / Seminar, Online



Credits / Hours

.2 CEUs



Presenters / Authors / Faculty

Suzan Olson, PhD, MHS, RN

Keywords / Search Terms

CfPA Human Factors, Medical Devices, ISO 62366:2015 and ISO14971:2007/2010, Human Factors Psychology, Computer Science, Engineering, Denovo, ISO 13485 Medical Devices, ISO 14791:2007/2010, ISO 62366 Part :2015 Seminar CE CME

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