Article | November 21, 2021

Simplifying Commercial Software Validation In Medtech Manufacturing

By James Jardine, MasterControl

iStock-1288116976-regulatory-compliance

Commercial off-the-shelf (COTS) software has dramatically enhanced medical device manufacturers’ ability to accelerate production, integrate processes, and manage quality effectively. Without straightforward guidance from regulators like the U.S. Food and Drug Administration (FDA), however, validation can be so overwhelming, impractical, and time consuming that it actually impedes progress. And when it comes to general guidance for validating commercial off-the-shelf software, FDA directives are nearly 20 years old.

Until an official CSA guidance is issued, medical device manufacturers are largely sticking to traditional methods of COTS software validation that have been cobbled together from various 21 CFR regulations. This approach s evolving to a more meaningful and effective form of validation that is far more efficient, and we owe that to technological innovations and the increasing regulatory emphasis on risk.

Just as device manufacturers are always looking for ways to reduce validation burdens, software vendors are continually looking for ways to help their clients accelerate validation processes. By leveraging the validation work vendors have already performed, device companies can focus their testing efforts on the features of the COTS software they implement that are most critical to their business practices.

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Med Device Online? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: