Module 14 2022

24/03/2022

POINT TO CONSIDER

● DOES IT NEED A SHELF-LIFE? – Is the design prone to degradation which will impair its functionality?

– What is the level of RISK associated with potential degradation?

Interactive Session

The Organisation for Professionals in Regulatory Affairs

9

Examples…

● Two different examples – Tongue depressor – Small likelihood of time-dependent degradation

– Cardiac pacemaker – Intended to treat a life-threatening condition – The failure rate should approach zero within the approved shelf-life

Interactive Session

The Organisation for Professionals in Regulatory Affairs

10

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