Building Compliant Software for Medical Devices

Klocwork's comprehensive static code analysis tools are used by medical device manufacturers to reduce liability and ensure standards compliance for C/C++, Java and C# software.

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Manage Software Risk in Medical Electronics

Medical devices are becoming more complex as the industry drives towards better features, increased connectivity and lower power requirements. With these efforts, risk management plays a vital role as medical device manufacturers focus on standards compliance and reducing the probability of occurrence of harm.

Software is the primary contributor to risk in medical devices and developers must ensure their code meets all functional, regulatory and time to market requirements. Klocwork Insight helps meet all these goals by providing early, rigorous detection of critical bugs, security vulnerabilities and standards compliance right at the developer's desktop. That's why many of the world's leading medical device manufacturers made Klocwork the standard in their software verification and validation process.

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.

The standard in software compliance

All aspects of medical software development are governed by regulatory compliance and Klocwork Insight has you covered. In addition to automatically detecting MISRA C and C++ coding standard violations, our tools address many validation requirements under the FDA General Principles of Software Validation and support unit, integration and system testing under IEC 62304.

Use Klocwork Insight on your project to provide evidence of compliance and reduce validation costs.

The authority in defect detection

Combining sophisticated control and data flow analysis, project-wide visibility and integration into many popular development environments, Klocwork Insight offers instantaneous feedback as developers write code. At its heart, hundreds of code checkers provide comprehensive coverage against many unforeseen errors.

This powerful system allows teams to fight defects before they're introduced into the population, resulting in reduced risk and faster time to market.