Medical Devices


Ensure IEC 62304 compliance

 

Software is increasingly used within Medical Devices as they become more complex and enable bio-science advances to be brought to the healthcare market. The costs of software failure in lost time to market from regulatory delays, brand reputation, litigation and even loss of life; together with increasing adoption of international standards are driving industry leaders to improve safety-critical software quality.

Medical device standards

Standards in the Medical device sector provide benchmarks for adhering to regulatory requirements both in the European Union and the United States. IEC 62304, Medical device software - Software life cycle processes, specifies life cycle requirements for the development to medical software and software within medical devices. The IEC 62304 standard also requires use of coding standards, such as MISRA and CERT.

IEC 62304

Medical Device Software - Software Life Cycle Processes

MISRA C/C++

Guidelines for the use of the C/C++ languages in critical systems

CERT C/C++

Secure Coding Standard

QA Systems testing tools

QA Systems enables organisations to accelerate IEC 62304, MISRA and CERT standards compliance with automated static and dynamic testing tools:

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