Diagnostic Reagent Blisters White Papers

Design, development and validation of point-of-care reagent blisters: A process walkthrough

by: J-Pac Medical

Design, development and validation of point-of-care reagent blisters: A process walkthrough

Introduction

The complexity that medical device manufacturers encounter when designing, developing and validating point-of-care diagnostic reagent blisters stems from the sheer number of moving targets they must keep in constant view. They risk underestimating or overlooking the critical technical and regulatory aspects that attend design, development and validation. This resource paints a start-to-finish picture manufacturers can use to smooth out the process and launch their products faster.

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