Medical Device Manufacturing Process Software Can Be Validated By Non-Experts

This article is intended to help ordinary users understand what software validation is all about, how to go about it, and what projects to leave to the software engineers. Software validation in the medical device industry is critical to the proper functioning of medical equipment. It is also FDA mandated that any software which automates any process that is part of a medical device must be validated. The article goes into depth about the specific FDA regulations regarding validation. The goal for these regulations is to make sure any medical device that uses software as part of an automated process is accurate, reliable, and consistently meets the requirements for its intended use. Usually, it falls to the end users to test and validate software. Those end users frequently have very little experience validating software. Off-the-shelf software and device-embedded software should be tested by non-technical users while custom programs should be left to software professionals.. Since validation is defined as having the software meet the requirements for its intended use, this article gives several steps to a successful validation: life cycle planning, identification of requirements and intended use, risk management, change control, and testing.  Read the full article at MCAD Cafe.

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