Originally Published MX September/October 2001

INFORMATION TECHNOLOGIES

Today's data-management software can track, trend, and report on quality issues through a product's entire life cycle.

Mark Schaub

These
days, medical device executives are paying more and more attention to the increased
scrutiny of FDA and other regulatory agencies—and rightly so. Top executives
of medical device companies are under a greater risk of liability than ever
before due to the increasing complexity of new devices and stricter regulatory
enforcement. What's more, keeping track of the mountains of clinical study and
other regulatory data generated by device companies is becoming increasingly
difficult. Medical device executives can avoid some of the risk by improving
their management of regulated data—information related to design control,
clinical trials, regulatory submissions, quality audits, reportable events,
and corrective actions such as recalls—by using software that allows them
to track, trend, and report on such data.

It's a Changing Marketplace