IEC 62304


Software quality for medical devices

IEC 62304


Software quality for medical devices

IEC 62304

IEC 62304:2006 (Medical Device Software- Software Life-cycle Processes) is a functional safety standard. A system to which IEC 62304 is applicable often has varying levels of risk to the user or different safety requirements. To accommodate this IEC 62304 has three Software Safety Classes (Class A, Class B and Class C), with Class C being assigned to software systems where death or serious injury is possible.

In the European Union compliance with IEC 62304 will satisfy the essential requirements contained in Medical Devices Directive 93/42/EEC (MDD) with amendment M5 (2007/47/EC) as related to software development. In the United States, the US FDA will also accept ANSI/AAMI/IEC 62304 as evidence that medical device software has been designed to an acceptable standard and covers the following regulatory processes: 510(k), IDE, PMA, HDE, Software Validation (FDA Recognition List Number: 020 Publication Date: 09/09/2008). The relationship of IEC 62304 to other standards is documented on Annex C. Of particular note is “Readers of the standard are encouraged to use IEC 61508 as a source for good software methods, techniques and tools while recognising that other approaches, both present and future, can provide equally good results.

Recommended tools for compliance with IEC 62304

QA Systems enables organisations to accelerate IEC 62304 compliance with automated static analysis and software testing tools:

Tool Certification & Qualification

QA Systems’ dynamic testing tool Cantata has been classified and certified by SGS-TÜV GmbH, an independent third party certification body for functional safety, accredited by Deutsche Akkreditierungsstelle GmbH (DAkkS). Cantata has been classified as a Tool Confidence Level (TCL) 1 tool, and is usable in development of safety related software according to IEC 62304:2006 up to SW safety Class C.

For our static analysis tool QA-MISRA, our tool Qualification Support Kit (QSK) automatically executes a full tool qualification verification test suite on the installed tool configuration and generates the necessary reports for IEC 62304 tool qualification.

These tool kits for IEC 62304 are available to ease our customers’ path to certification. They contain everything needed to prove that Cantata and QA-MISRA provide the required confidence in the use of software tools under IEC 62304 recommendations as well as comprehensive and detailed guidance on how to use them to comply with the required software verification activities of IEC 62304.

Please contact us for more information about these tool kits.

Cantata Certificate

Software testing for IEC 62304 compliance

The Cantata testing tool enables developers to automate unit and integration testing and to verify IEC 62304 compliant code on host native and embedded target platforms.

Cantata helps accelerate compliance with the standard’s software testing requirements by automating:

  • Test framework generation
  • Test case generation
  • Test execution
  • Results diagnostics and report generation

Please contact us for more information on Cantata for IEC 62304.

The IEC 62304 software testing recommendations by Class and how these are supported by Cantata are summarised in our White Paper “Cantata Standard Briefing IEC 62304:2006”.

Start a free trial & get a complete copy of Cantata to evaluate using your code.

Static analysis for IEC 62304 compliance

Coding standards form an integral part of software acceptance criteria within the IEC 62304 standard.

The guidance in Annex B.5.5 explains the rationale as “To consistently achieve the desirable code characteristics, coding standards should be used to specify a preferred coding style. Examples of coding standards include requirements for understandability, language usage rules or restrictions, and complexity management.” Static analysis with QA-MISRA can dramatically reduce the manual effort in enforcing compliance with such coding standards. 

The IEC 62304 static analysis recommendations by Safety Class and how these are supported by QA-MISRA and Astrée are summarised in our “QA-MISRA Safety Manual”

Start a free trial of QA-MISRA to evaluate your code against MISRA, AUTOSAR, CERT C/C++, CWE and other coding standards to ensure automated compliance with IEC 62304.