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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.

Solutions for medical devices from 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_logoA 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.