Module 14: Design Development and Certification of Medical Devices

22/11/2023

DESIGN OPTIMISATION

Personal experience ● BAYER CONTOUR NEXT BLOOD GLUCOSE METER – New model ● WiFi-connected ● Download data + e-mail data to HCP ● Removable button batteries ● Allows “topping up” of partially filled blood strip. ● New “ergonomic” shape ..?

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

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EXAMPLE DESIGN OPTIMISATION

Personal experience ● ACCURACY -assumed ● WiFi-connected? – Needs WiFi signal! ● EASY TO DOWNLOAD ● Removable button batteries:

– Need to carry spares… – Arrives with the battery indicator showing half-full.. – Is the battery half-full …or half-empty?

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

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