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Medical Devices


Delivering results for a healthy market

The use of embedded software in medical devices is increasing rapidly. The medical market is expected to become one of the most significant growth areas for embedded software development, thanks to the widespread development and adoption of devices, diagnostic tools and home care solutions. Any company active in this exciting and rapidly expanding market must ensure the highest quality of software development.

Meet IEC 62304 Industry Standard with PRQABy adopting and enforcing a demonstrable commitment to software quality, practitioners in the medical device market are better positioned to meet legislative and regulatory requirements. In particular, coding standards are “best practice” when developing embedded software, and equip your development team with the right approach to meeting even the most stringent demands.

Our leading static analysis tools QA·C and QA·C++ provide the flexibility to introduce and enforce various coding standards that ensure quality, safety and reliability. And QA·Verify provides a reporting framework to document and demonstrate compliance to standards over time and across product versions.

 

IEC 62304 certified

SGS TUV SAAR CertificationA key standard in the medical device software industry is IEC 62304 – a global benchmark for management of the software development lifecycle. Designing to IEC 62304 ensures that quality software is produced by means of a defined and controlled process of software development.

Following an independent audit by SGS-TÜV SAAR, both QA·C and QA·C++ – when used with our MISRA C Compliance Module and as outlined in the Safety Manual – are certified as “usable in the development of safety related software” for they key safety critical standard: IEC 62304 up to SW safety Class C.

 

PRQA Static Analysis Products

        Yves Willems, Software Engineering Manager at Biocartis NV:

c++ coding standards

 

“Biocartis has used QA∙C and QA∙C++ during the development of IEC 62304 compliant software (safety Class C) for the Idylla™ IVD (medical) device. We apply MISRA based coding guidelines and have been very impressed by the ability of QA∙C and QA∙C++ to find issues that other tools miss and also the low level of false positives (noise).” 

 

 

“Although our Idylla™ system software has been classified by FDA as IEC 62304 Class ‘C’ software, we decided not to perform systematic code reviews because the code base is big and complex and because we believe code reviews are not effective. To justify this decision we decided to go for a top class static code analysis tool from PRQA. The tool was selected for its rich C++ feature set, accuracy, flexible configuration, automated build tool integration capabilities and good customer references.”