Module 14: Design Development and Certification of Medical Devices

17/11/2023

Design Planning and Design Control

21 st November 2023

Jonathan Bradshaw

Head of Development and Systems Engineering - OOONO Medical A/S

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in 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