

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 - FDA Software Validation
FDA Software Validation Guidance
When building safety-critical medical device software, implementing early, rigorous detection of critical bugs and security vulnerabilities is a proven best practice for enhancing 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 has issued guidance for proper validation of medical device software in the form of the General Principles of Software Validation. The guidance applies to any "...software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer's quality system."
The FDA's guidance covers all aspects of software development - everything from requirements and design reviews to software maintenance and retirement. Klocwork Insight can address the following validation requirements as they relate to the software construction or coding phase:
| FDA Guidance | Klocwork Support | |
| 3.1.2 | Software Verification |
Klocwork Insight Pro is a leading static code analysis solution that provides development teams with:
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| 4.2 | Defect Prevention |
Static source code analysis technology allows development teams to find a wide range of defects prior to QA. Uniquely, Klocwork's Continuous Desktop Analysis enables developers to find bugs at their desktop, prior to code check-in. This enables "in-phase bug containment", which ensures:
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| 4.7 | Software Validation after a Change |
Klocwork allows developers to easily validate the impact of any changes:
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| 4.9 | Independence of Review |
By its nature, the use of automated source code analysis provides an independent, automated review of source code.
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| 5.2.4 | Construction or Coding
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Klocwork Insight is used primarily during the coding or construction phase of the software lifecycle:
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| 5.2.5 | Testing by the Software Developer |
Klocwork Insight is designed to be used by the developer, at their desktop and supports the identification of multiple forms of dead code including unused code and unreachable code. |