Design Controls & Risk Management

An Integrated Product Development Approach

The course is 2 days of intensive workshop instruction which provides an integrated analysis of design control & risk management regulation concepts (21 CFR 820.30/ISO 13485 / ISO 14971) in a product development context. The course agenda walks attendees through a typical product development lifecycle which is broken out into five development phases. Workshops, exercises and quizzes are introduced throughout the course to reinforce principles and to provide attendees with a practical and hands-on experience.

This workshop is appropriate for medical device professionals with minimal to moderate experience with design control regulation. This course uses a unique blend of instruction from industry experts and resources from FDA regulation and guidance.  

Training Experience 2

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Course Objectives

  • Gain a solid understanding of design control and risk management regulation concepts
  • Develop a skill set for implementing design controls and risk management best practices
  • Learn how to integrate design control and risk management regulation into the project management process
  • Learn how to integrate a phased development approach into the product development lifecycle
  • Develop methods for integrating risk management across all design control elements
  • Recognize the differences between 21 CFR 820.30 and ISO 13485 design controls

Included with the Course

Course Agenda

Instructor Bio