Module 14 2022

14/03/2022

Design Planning and Design Control

24 th March 2022

Jonathan Bradshaw

Systems Engineering Lead, Phillips-Medisize

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

1

Learning Outcomes

• The key distinctions between different types of design control, and their importance in delivering safe and effective medical devices.

• Understand how design control can be used effectively whilst promoting the growth of knowledge and design space.

• The role of effective design planning in ensuring appropriate inputs are developed.

• How design inputs are translated into design outputs through an iterative design process.

The Organisation for Professionals in Regulatory Affairs

2

1