Coverity Medical Device Solutions
Over 20 million shipped medical devices, including pacemakers, infusion pumps and defibrillators have been tested with Coverity.
Test Your Software Code, Manage Safety Risks, Control Compliance
The use of software in the medical device industry is exploding: Software is embedded in devices, used as diagnostic tools, and relied on to develop and test new devices. Not only is the size of codebases growing, but the software itself is gaining in complexity. Software can enable medical device manufacturers to deliver innovative breakthrough devices that help patients lead better lives, but it needs rigorous testing to ensure patient safety in the field and to meet compliance standards. The cost of software defects is staggering: even one field failure or recall can cost a manufacturer millions, not to mention the immeasurable risks to patient safety.
Coverity's development testing platform can be easily adopted as part of your medical device software development and verification process to identify defects early in development as the code is being written, when it's the least expensive and easiest to fix, instead of testing quality into the software after the fact.
In a recent 5 year period 11.3% of medical device recalls were attributed to software defects, and 49% of recalled devices relied on software in some way.
- Institute of Medicine, 2011
Prepare for FDA Compliance
Software code testing via static analysis is an FDA recommended testing activity according to the as a method to detect and prevent runtime errors. See how Coverity can help you meet FDA guidelines for software verification, defect prevention, software validation after a change, need for independent review, ensuring coding guidelines, and developer testing. Coverity can assist you in building audit documentation for the regulatory process, while building long-term best practices into your software development cycle.
Experience That Matters
Coverity works with over 20 of the world's leading medical device manufacturers to meet the highest levels of product safety and quality in a variety of life sustaining devices by identifying software defects early in the development cycle that can lead to product crashes, security breaches, unexpected behavior, or catastrophic field failure.
Leverage Coverity's Medical Device Software Testing Solutions
Effectively set and monitor FDA compliant quality and security thresholds during your development testing cycle using Coverity Integrity Control. Test your code and triage your high-risk defects using Coverity Static Analysis. For more information and a look at our development testing suite, register today for your .
Meet Internal & FDA Compliance
Coverity® Integrity Control helps you define the software testing policies for code quality and security that matter to your organization, based on the internal standards and specific FDA regulations, and automatically report on adherence to these policies as part the FDA pre-market submission process or ongoing validation as software is changed post-release.
Identify Code Defects
Coverity® Static Analysis identifies high-risk defects that could result in runtime errors that can affect the integrity of your devices, without compromising your development cycle. Learn more about the with Coverity Static Analysis.
Explore Featured Content
Download our latest whitepaper and learn how to establish a three-step solution that will assist you in the FDA regulatory process while building long-term best practices into your software development cycle.
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