Building Compliant Software for Medical Devices

Klocwork's comprehensive source code analysis tools are used by medical device companies to help ensure FDA compliance and software reliability for C/C++, Java and C#.

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Adhere to FDA Software Validation Guidelines

When building safety-critical medical device software, implementing early, rigorous detection of critical bugs and security vulnerabilities enhances software reliability while reducing software validation costs. Many of the world's leading medical device manufacturers have made Klocwork a standard part of their software development and validation process.

The FDA's guidance covers all aspects of software development from requirements and design reviews to software maintenance and retirement. Klocwork Insight supports many validation requirements and you can find a list of Klocwork support for each applicable FDA Guidance here.

As a medical device developer, our software can have a profound impact on peoples' lives. We therefore do everything possible to ensure that our work product is of the highest quality...Klocwork has become one of the most important tools in our arsenal.

Dan Sterling

President, Sterling Medical Devices

Resources

Case Study: Johns Hopkins Enhancing Software Reliability

Case Study: Johns Hopkins University

Klocwork helped the JHU Applied Physics Laboratory team ensure software reliability while saving them 900 person hours over 5 months. Learn more.

White Paper: Software Verification for Medical Devices

Medical Device Software Verification

In this white paper for medical device manufacturers, learn how an effective verification process can help achieve FDA compliance. Learn more.

Find defects the moment they're introduced

Similar to the spell check feature in popular word processors, Klocwork Insight instantly underlines defects as developers are writing their code.

Sophisticated syntax and dataflow analysis, build comprehension, and incremental analysis are continuously running to ensure thorough and highly accurate identification of security vulnerabilities and critical defects. With an analysis time measured in milliseconds, developers of medical software can ensure the security and reliability of their code right at the desktop.

About Klocwork

Klocwork helps developers create more secure and reliable software. Our tools analyze source code on-the-fly, simplify peer code reviews, and extend the life of complex software.

Over 1000 customers, including the biggest brands in the mobile device, consumer electronics, medical technologies, telecom, automotive, military and aerospace sectors, have made Klocwork part of their software development process.