Module 14: Design Development and Certification of Medical Devices

22/11/2023

Masterclass: Lecture 15

The Organisation for Professionals in Regulatory Affairs

17

EXAMPLE of a LIFE CYCLE CHANGE FOR AN IVD DEVICE

BLOOD GLUCOSE METERS • In vitro diagnostic devices •

a critical tool for insulin-dependent diabetics • Comprise: • Meter • Test strips • Lancets • Lancing device

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

18

9