Intertech Engineering Associates, Inc.

Medical Device Validation Series. Part 1 of 4

Medical Device Validation Series. This is part one of a four-part series on medical device validation practices.

Part 1, Introduction

The Food and Drug Administration (FDA) pays special attention to software because it is now embedded in a large percentage of electromedical devices, and the amount of device functionality controlled by software is continually growing. Software also controls many of a medical device manufacturer’s design, development, manufacturing, and quality processes, regardless of whether software is a part of the manufactured device.

Software failures often can be invisible and difficult to detect; thus, these failures can have disastrous consequences on the operation or quality of medical devices. For this reason, the FDA specifically requires validation of both device and quality-system automation software. Validation activities are meant to keep defects from getting into the software, as well as to detect and correct any defects that do end up in the software.

The FDA’s control over software used by medical device manufacturers is detailed in the Quality System Regulations (QSRs) found in FDA regulation 21 CFR 820. Software regulations focus on the development and use of two large categories: (1) software that is part of the device being manufactured and (2) software that is used to design, develop and manufacture the product or otherwise automate any part of the quality system.

Guidelines for complying with the FDA’s regulations are published by the agency as a “Guidance Document”. These documents are updated periodically, and new a guidance is issued as the need arises. While compliance with the guidelines is voluntary, the device manufacturer should be prepared to explain and defend any deviation from the guidances.

The most important FDA guidance available for the validation of software is the General Principles of Software Validation (GPSV), and can be obtained for free from the FDA’s website (https://www.fda.gov/downloads/MedicalDevices/…/ucm085371.pdf ). This is a “must read” for all software engineers and quality engineers working with software in the medical device industry.

From: Vogel, David A., Ph.D. “Validating Medical Device Software Includes and Goes Beyond Testing.” Medical Product Outsourcing Mar. 2006

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