Module 14: Design Development and Certification of Medical Devices

17/11/2023

Verification

Outer Diameter

MATH MODEL & 3D SIMULATION

Knowledge Space Exploration

Outer Diameter Variants SLA Components

Knowledge Space Verification

Empirical Test Data Injection Moulded Components

The Organisation for Professionals in Regulatory Affairs

25

Validation

1,000,000’s

1000’s

100’s

Rapid Prototype Rapid Manufacture

10’s

The Organisation for Professionals in Regulatory Affairs

26

13