Module 18 2021

08/02/2021

Selecting a Process

Device Form Development

Cup Seal Development

Proof of Concept: Functional Level

Proof of Concept: High Level

The Organisation for Professionals in Regulatory Affairs

15

Device Form Development

Output: •

Output: •

Output: •

Handling Study

Summative HF Study

Preference Study

Function Requirement: • Selected functions • Mimic final finish

Function Requirement: • Fully functional • Mechanical operation

Function Requirement:

Mimic final form

•

Life Requirements:

Life Requirements: • Medium term

Life Requirements: • Long term

Short term

•

Quantity:

Quantity: •

Quantity: •

1-2 components

•

~10 components

100+ components

SLA

IM Prototype Tooling

FDM

Vacuum Casting

The Organisation for Professionals in Regulatory Affairs

16

8