Module 14: Design Development and Certification of Medical Devices

22/11/2023

LIFE CYCLE CHANGE FOR AN IVD DEVICE

Diabetic - personal experience (HE) ● BLOOD GLUCOSE METERS

● MULTIPLE versions available… – CHOICE usually comes down to Nurse recommendation, or the usability of the LANCING DEVICE that comes with it – More complex to use than it needs to be – HUMAN FACTORS … not a great success here!

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

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● BAYER CONTOUR NEXT BLOOD GLUCOSE METER – Version 2015 LIFE CYCLE CHANGE FOR A DEVICE

● USB-connected ● Download data / e-mail data to HCP ● Charge from laptop (or via USB phone charger) ● Allows “topping up” of partially filled blood strips

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

20

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