Design Control for Medical Devices

• Design and development planning
• Design input
• Design output
• Design review
• Design verification
• Design validation
• Design transfer
• Design change control
• Design history file
• Toll Gate Management (TGM)

Programme overview

This Medical Device Design Control training course is a designed to introduce the trainee to the Device Design Control process  & tools required to effectively manage  the process.

Who is the course for

This course is designed for Senior Management, Product Design Managers, Process Engineers, Manufacturing Cell Business Owners, Production Team Leaders QA and Regulatory personnel working on Medical Device Design Control systems.

Learning outcomes

Learners will have a complete understanding of:

The Device Design Control system

Regulatory audit approach to Design

How to evaluate your own Design system