IEC 62304 Compliance

for IEC 62304 Class-A, Class-B and Class-C

SGS TUEV SAAR Approved for functional safety sign

Software is often an integral part of medical device technology. Establishing the Safety and effectiveness of a medical device containing software requires knowledge of what the software is intended to do and demonstration that the use of the software fulfils those intentions without causing any unacceptable Risks (IEC 62304:2006).

The Static Codeanalysis Package of the Axivion Suite is certified by SGS-TÜV Saar GmbH for use in the development of safety systems according to IEC 62304 up to Class C.

IEC 62304 describes the Software life cycle processes containing the Development and Maintenance Process, Risk Management (incorporating ISO 14971 and the Technical Report IEC / TR 80002-1), Configuration Management Process and Problem Resolution Process.

Axivion TUEV certificate number FS 71 220 21 0690

IEC 62304 defines three severity levels:

Class A: No injury or damage to health is possible
Class B: Non-serious injury is possible
Class C: Death or serious injury is possible

Axivion Suite supports the development of Software
for Medical Devices for all severity levels

In the development process Axivion Suite supports you during the Software architectural design and detailed design with Axivions architecture verification.

During Software verification and testing on unit, integration and system level Axivion Suite supports you with checks for MISRA C, MISRA C++, AUTOSAR C++14, CERT, ISO/IEC TS 17961 or custom coding rules specific for your environment.

It is possible for software defects to lead to errors in unrelated software running on the same hardware. Segregation is a strong goal in ICE 62304 projects. Axivion’s Architectural verification can help identifying potential violations early on source code level identifying function calls between various severity classes. This could help saving time running less frequent into exceptions from the MMU/MPU later in the development cycle.

Depending on your use case the Axivion Suite might be classified in the project and hence must be qualified to the respective TCL level. Axivion provides a Tool Qualification Kit. The Kit contains a set of violations of MISRA, CERT and AUTOSAR C++14, which allow you to qualify your current setup to any Severity Level and use case.

Axivion Suite integrates with almost any CI-System which allows for repeatable and comparable analysis of software. At the same time Axivion Suite could run also locally allowing for fast checks and short roundtrip times.

A safety analysis with Axivion brings in all the strengths and features of the Axivion Suite such as Architecture Verification, Clone Detection, Metrics Monitoring, Styleguides (MISRA, CERT, AUTOSAR C++14), Dead Code Analysis and Cycle Detection together with the qualification required by the respective TCL by the Tool Qualification Kit for any severity level (Class A, Class B or Class C) from IEC62304.