Medical Device Design Controls

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Good manufacturing practices (GMPs) are the regulations enforced by the United States Food and Drug Administration (FDA) for medical devices. Part of these regulations include controls for medical device design and development. These specific design and development regulations are termed “Design Controls” and are referenced in the US Code of Federal Regulations Part 820.30 (CFR 820.30).  They are the application of a formal methodology for design and development of some Class I devices and all Class II and III devices marketed in the United States.  In this course you will gain an understanding of these regulations and how they work to ensure that devices meet user needs and intended uses.



This course is available online, and can be taken at your own pace.

Please note: You must complete the course within 3 months of registration.

Course Features

  • Lectures 0
  • Hands-On Training 0
  • Duration 3 hours
  • Skill level All levels
  • Wet Lab No
  • Max Students 75
  • Assessments Yes