In one FDA analysis, 7.7% of medical device recalls were attributable to failures in the software involved in the design and production of the device. Of those, nearly 80% were caused by defects introduced when changes were made to the software after initial production and distribution.
FDA software validation is required to ensure regulated manufactured medical device products meet a standard for safety and effectiveness for the public. The FDA wants a robust audit trail, so if a device fails, they can examine the steps leading up to the failure to uncover the root cause.
Software validation must be done throughout the software lifecycle, from quality planning to retirement. The responsibility of software validation falls on the shoulders of the medical device manufacturer, not the software vendor.
In this Q&A with Dominic Mancini, Vice President of Columbus Global partner Arbour Group, which specializes in software testing validation and verification services, you’ll learn:
- Where to start compliance preparations
- Considerations with FDA software validation in the cloud
- How to stay compliant when you have frequent software updates
- Best practices in FDA software validation
- Keys to selecting the right partners for your ongoing validation needs