Biomedical Engineering’s Role in FDA & ISO Compliance

Biomedical device design engineers, manufacturing engineers and quality engineers gain an understanding of FDA requirements and how they compare to ISO requirements. Understand the need for regulations for medical devices and gain valuable insights into making your products compliant.

This course can be applied to the Plastics Technology Certificate.


John Ziobro

John Ziobro has over 30 years of expertise in the medical device industry. He holds a Bachelor of Science in mechanical engineering from the University of Wisconsin-Madison. He is the co-inventor of a U.S. patent for heat-removal method and apparatus ... read more

Benefits and Learning Outcomes

  • 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

2.FDA v. ISO

  • Device classifications
  • Clearances or approvals

3.Guidance Documents

4.Why Regulations?

  • Safe and effective products
  • Substantially equivalent

5.Requirement Exercises

  • PRD and predicate
  • Test and measurements
  • FMEA
  • CAPA

Session includes lectures, Q&A and group/individual exercises

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

Date: Wed, Apr 22

Time: 8am-4:30pm

Location: UWM School of Continuing Education

Instructor: John Ziobro


$495 by Sat., Feb. 22.
$595 after Sat., Feb. 22.

CEUs: 0.7, PDHs: 7.0

Enrollment Limit: 40

Program Number: 4830-12476

Registration Deadline: Wed., Apr. 22

Register Now