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May 2015


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How to Develop a Medical Device Design Control Program that Will Meet FDA Requirements

Online Event


Event Overview:

This training program will offer attendees an understanding of the reasons for design control and highlight the key elements of a design control program. The FDA has concluded that a well-controlled design process with risk analysis, change control, design reviews and hardware/ software validation will greatly reduce the chances of an unsafe product. In accordance with the same, This webinar will also discuss how risk management fits into design control compliance.

Why Should You Attend:

This course will explain how to setup and manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. A design control program will also help ensure your projects are completed on time and within budget.

The other key learnings in the course include:

  • The important question of when, in a development process, design control begins will be answered.
  • The difference between pre-release and post release change control will be established.
  • The design history file will be explained and a contents checklist discussed.

Areas Covered in the Webinar:

  • Understanding the reasons for design control
  • Understand the elements of a design control program
  • How risk management fits into design control compliance
  • Understand change control including requirements changes
  • Understand validation consists of more than testing
  • Building a design history file (DHF)

Who Will Benefit:

  • Personnel developing or managing medical devices
  • Production management
  • QA/QC
  • Software engineers

Instructor Profile:

Edwin Waldbusser is a consultant retired from the industry after 20 years in management of development of medical devices (5 patents). He has been consulting on regulatory issues related to design control, risk analysis and software validation for the last 7 years. Mr. Waldbusser has a BS in mechanical engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness Network.

For Registration

Note: Use coupon code 232082 and get 10% off on registration.




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