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Relevant Reads

WHITEPAPER: Embedded Open Source Analysis

This white paper highlights the results from an analysis of multiple open source projects that are commonly used in embedded development [...]

FACT SHEET: FDA Software Validation Guidance

Automated source code analysis is technology aimed at locating and describing areas of weakness in source code. [...]

CASE STUDY: Schiller Case Study

As a market-leading provider of healthcare technology, Schiller has a commitment and a responsibility to ensuring their products have a wide range of functions while maintaining a high level of reliability [...]

Solutions - Medical Devices

When lives are at stake, there's no margin for error. Critical software bugs, such as quality defects, are simply unacceptable in medical devices. Yet, medical device software development teams are under many of the same pressures as those in other mission-critical industries.

As with the general software development community, medical device companies are striving to differentiate their products based largely on features supported by software. Demands for more speed, lower power consumption, and sophisticated-yet-intuitive user interfaces are driving application size, as well as code complexity.

Optimizing developer productivity is a key strategy in achieving on-time project delivery and software quality targets in the medical device market.

Focus on developer productivity is the key

Static analysis does not require code execution so there is no need to setup a multitude of production scenarios and settings, and test cases are not needed. By the time the development team is ready to test all software components, serious coding defects will be removed, enabling more efficient functional and shorter FDA validation cycles.

Early Testing for Higher Quality

By enabling developers to identify and fix critical bugs of all kinds while they are working, Klocwork static analysis makes it possible for medical device manufacturers and their suppliers to conduct early testing for serious, crash-causing defects in code. This can be done at compile time, well before any integration, module or unit tests begin.

Enabling Regulatory Compliance

Medical device manufacturers can face crippling costs when software fails in the field, as well as being subject to regulatory compliance in many industries. Klocwork Insight can assist organizations in addressing many of these requirements and it helps organizations to demonstrate that they are:

Addressing the FDA's software validation guidance [MORE]
Implementing consistent coding standards at developers' desktops [MORE]
Focusing on early prevention of defects [MORE]
Verifying software in addition to QA [MORE]
Documenting system design and/or structure [MORE]