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.


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


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


  • 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

All sessions are Face-to-Face unless otherwise noted.

Date: Wed., Oct 24

Time: 8am-4:30pm

Location: UWM School of Continuing Education

Instructor: John Ziobro

Fee: $395

CEUs: 0.7, PDHs: 7

Enrollment Limit: 40

Program Number: 4830-11154

Registration Deadline: Wed., Oct. 24

Register Now