Learning Marketplace

Understanding Medical Devices Design Controls


BSI’s “Understanding Medical Devices Design Controls” course is designed to provide participants with an understanding of the impact that ISO 13485:2003 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals gain an understanding of how ISO 13485:2003 can improve their business and design control efforts. The training includes exercises, and participants will have the chance to ask questions about how ISO 13485:2003 for design controls and risk management apply to their organizations.


Learning objectives

  • Understand the role of design controls in the medical device industry
  • Practice the basics of design controls
  • Interpret the clauses of ISO 13485:2003
  • Recognize the application of process and product validation concepts
  • Understand the importance of management involvement with ISO 13485:2003 implementation
  • Understand the impact of ISO 13485:2003 implementation on medical device organizations
  • Identify the recent changes and how they will impact an organization wishing to sell devices globally
  • Consider the life-cycle concept and how it applies to the design control process

Course materials

Students receive comprehensive course manuals with reference materials.

Who should attend?

  • Quality managers or implementers within an organization seeking or maintaining registration to ISO 13485:2003
  • Decision makers on management system strategy
  • Design Engineers, Process Engineers and Manufacturing Engineers
  • Internal Auditors
  • Management Team 


Course times

  • Day 1:  8:00 am – 5:30 pm


Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Recommended is a basic awareness of medical devices, quality assurance, and ISO 13485:2003.

Course logistics

Certificates of attendance are provided at the completion of the course.

Student : Instructor Ratio – 20:1