A Prudent Investment

Investing in the right software keeps you on the leading edge of productivity and compliance.

By: Mark Crawford, Contributing Writer

From: Medical Products Outsourcing

April 2011

It’s confusing and costly, but taking the plunge and investing in advanced software solutions could be the smartest capital investment you make this year, with a payback period of six to 12 months after implementation.

In many ways, software is the magic bullet for everything medical device manufacturers (MDMs) or their suppliers find vexing, such as adverse events, slowdowns, communication failures, U.S. Food and Drug Administration (FDA) recalls and validation issues. Across the increasingly complex compliance landscape, software is essential for adhering to worldwide standards, such as ISO 13485, ISO 14791, 21 CFR 820, 21 CFR Part 11 and others. Precious,glorious speed—from reacting quickly to changing market needs to submitting electronic medical device reports (eMDRs) to managing product complexity—is driven by software.