MEDICAL DEVICES

Ensure IEC 62304 compliance

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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 safety standards compliance with automated static analysis and software testing tools:

STATIC ANALYSIS

INTEGRATED STATIC ANALYSIS

Automated analysis synchronised with Cantata

CANTATA TEST ARCHITECT

Understand, define and control software architecture

SOURCE CODE METRICS

Automated source code metrics for C/C++

SOFTWARE TESTING

CANTATA

Automated unit and integration testing for C/C++ code

CANTATA TEAM REPORTING

Test status management dashboard add-on

ADATEST 95

Automated unit and integration testing for Ada code

“We have standardized now on Cantata - it will be used for all new C or C++ developments”

Hamilton Medical

“I hope that all new projects will consider using Cantata"

GE Healthcare

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