FDA & ISO Requirements for Medical Devices

Medical device design engineers, manufacturing engineers, and quality engineers will gain a valuable understanding of FDA requirements, which will be compared to ISO requirements. Understand the need for regulations for medical devices and gain valuable insights to make your products compliant and fail safe.

This course can be applied to the Plastics Technology Certificate.

Instructor

Terry  Layton, Ph.D.

Terry Layton, Ph.D.

Dr. Terry Layton has 40 years of experience in the medical device industry. He is a technical executive with strong background in building medical device manufacturing companies. His diverse experience includes industry and consulting work in product development, regulatory/QA, operations, IP, ... read more

Benefits and Learning Outcomes

Learning Objectives:

  • Understand the FDA requirements and how they compare with ISO requirements
  • Learn what guidance documents are and why they matter
  • Explore why regulations are necessary
  • Engage in group exercises to gain practical insights.

Course Outline/Topics

1.FDA

  • History
  • 21CFR800 & 820
  • Design Control
  • Quality System Regulations

2.FDA v ISO

  • Device Classifications
  • Clearances or Approvals

3.Guidance Documents

4.Why Regulations?

  • Safe & Effective Products
  • Substantially Equivalent

5.Requirement Exercises

  • PRD & Predicate
  • Test & Measurements
  • FMEA
  • CAPA

Session will include lectures, Q&A and group/individual exercises

Dates and locations to be announced.

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