Module 14 2022

22/03/2022

TYPICAL VALIDATION STUDIES • Clinical studies / clinical evaluations •

Simulated use testing / Human Factors testing

• Information on substantially equivalent devices

• Transit trails to determine packaging stability

Stability studies

• Performance and functional tests

•

Literature searches

Biocompatibility tests

•

•

• Review of labelling for USABILITY and ease of understanding • Review of product packaging and its role in protection

• Software validation (beta testing)

Risk analysis from the user perspective

•

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

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GOOD DESIGN PRACTICE

DESIGN TRANSFER ● A critical part of product realisation – …and often poorly done.

● The manufacturing function must be involved in the design phase – To avoid failures in design transfer

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

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