IVD Technology

May/June 1998
Selected Contents

Cover Story: Dispensing systems for miniaturized diagnostics
by Thomas C. Tisone

Advances in IVD technologies, including the rapid growth in the field of point-of-care tests, are continuing to challenge the capabilities of existing systems for dispensing diagnostic regeants. But equipment manufacturers are showing that they're up to the task.

Purchasing controls for IVD manufacturing
by Russ Hangos

A significant number of product recalls have occurred because device manfacturers did not have adequate means of controlling the quality of the products and servies they purchased. Manufacturers can prevent such occurrences by complying with the requirements of FDA's new quality system regulation.

Design considerations for IVD clinical trials: Time-staggered multiple end points and related issues
by Cheryl L. Hayden and Michael L. Feldstein

A clinical study using multiple end points offers several advantages that can justify its increased complexity and potentially greater costs — including improved flexibility in preparing regulatory submissions.