The Importance of Software Safety Certification for Medical Devices and Equipment

Bill McCaffrey

May 31, 2016

A wide variety of medical devices incorporate embedded software. Some of these devices such as: X-ray scanners, heart rate, blood pressure, and breathing monitors, are used for analyzing patients. Others such as defibrillator and medication pumps are used to treat patients. In both cases, patient health and safety depend on the medical software deployed being reliable, safe, and bug-free.

In order to provide thorough and rigorous examination of the software systems on these devices, developers must comply with the guidelines outlined by the U.S. Food and Drug Administration (FDA) and/or the ISO standard IEC 62304.

FDA General Principles of Software Validation
Medical devices sold in the United States must be approved by the U.S. Food and Drug Administration. The FDA has defined a formal process for device manufactures to follow for certification including guidelines for software validation. The software testing requirements specified in “General Principles of Software Validation; Final Guidance for Industry and FDA Staff” are applicable to the development of Class II, III, and some Class I medical devices.

IEC 62304 Standard
The International Electrotechnical Commission created the ISO standard, IEC 62304. The standard, formulated to govern the requirements for medical software, describes the process that medical software must go through in order to be approved for use in Europe. The standard includes guidelines for testing any software components that are part of a medical device.

What is VectorCAST for FDA and IEC 62304
The VectorCAST Automated Test Platform for embedded software testing supports the creation and management of test cases to prove that the low level software requirements have been tested and is also useful for a variety of robustness testing activities such as range and out of bounds testing. Additionally, VectorCAST supports the capture and reporting of structural code coverage at all levels recommended by IEC 62304.

VectorCAST provides tool validation in the form of qualification documents. The qualification documents consist of Tool Operational Requirements (TOR) and Tool Qualification Data (TQD). TOR describes requirements for VectorCAST tools and TQD, the associated tests and test results. These documents are built for each project and the tests execute on the same compiler/target/runtime environment used by the customer.

The VectorCAST Medical Device Software Compliance Kit for FDA and IEC 62304 includes all necessary documentation for validating embedded software components used on all classes of medical devices. The kit includes test procedures, plans, coverage and test case reports necessary for Intended Use Validation, and to demonstrate due diligence with FDA and IEC 62304 software quality requirements.

To learn more download our whitepaper: Using VectorCAST to Satisfy FDA Software Testing Requirements.