Medical Device Design Control Training

  • Overview
  • Sample Agenda
  • Learning Outcomes
  • Who Should Attend?
  • Trainer Profile

NSF’s team of experts offers participants a hands-on approach to design control. This course provides you with an understanding of design control requirements relative to FDA’s 21 CFR 820 and ISO 13485:2016, as well as the knowledge to assist in all phases of your design project.

Sample Agenda

The agenda for our design control training class might look like this:

  • Welcome and introductions
  • Risk management
  • Design planning, inputs, outputs and review
  • Design verification and validation
  • Design transfer, change and design history files
  • Questions and answers

Learning Outcomes

Upon completion of this course, you will be able to:

  • Identify regulatory requirements for risk management
  • Recognize risk management definitions and principles of ISO 14971
  • Identify how risk management affects quality management system practices
  • Recognize regulatory expectations relative to design control requirements

Who Should Attend?

This course is vital for any medical device quality professional, as well as R&D and QA engineering professionals.

Trainer Profile

NSF's courses are taught by experts who have years of experience in medical device quality standards and regulatory requirements. Our trainers are committed to creating a learning environment that is highly interactive and based on real scenarios to help you apply practices and improve behaviors within your workplace. Learn more about our trainer for this course:

Robert Ruff, Executive Director, Medical Device Education and Training

Upcoming Courses & Webinars

In Medical Device Design Control Training
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      To view a full list of courses, please visit the course schedule.