Pre-certified software for standards-compliant medical product development

January 31, 2014 // By Graham Prophet
To simplify the standard-compliant development of medical products, Embedded Office is offering its “Cert-Kit µC/OS-II for IEC62304”. By using the real-time kernel µC/OS-II as a pre-certified component, this product facilitates the development of safety-critical applications and considerably reduces the certification process.

Software plays an important role in modern healthcare. Medical products and systems employed in analysis, diagnostics and treatment feature an ever-increasing amount of embedded software for controlling processes, for the computation and depiction of results as well as for control purposes. The health and safety of the patients depends however on the software used functioning reliably and accurately. The Cert-Kit comprises all the elements required for creating an executable application. These include the certified source code, various software manuals such as safety, target integration, user, reference and system manual. The Cert-Kit also contains validation software (including reference board support package) and the TÜV certificate pertaining to the type approval of the pre-certified software component.

The certification has been performed on the Infineon XE167 microcontroller according to IEC62304. The standard IEC62304 defines the life cycle requirements of software in medical products. It applies for development and maintenance. The set of processes, activities and tasks described in this standard establishes a common framework for all medical device software life cycle processes. The Cert-Kit provides flexibility so Embedded Office can adapt the certification of µC/OS-II with minimum effort to other CPUs and development environments.

Upon request, the test environment can also be made available to customers. Functional safety during the project implementation phase is ensured at Embedded Office by the Functional Safety Engineer Wolfgang Engelhard (TÜV FS Eng 4424/11).

µC/OS-II is a portable, ROM-capable, scalable, pre-emptive, deterministic real-time kernel for microprocessors, microcontrollers and DSPs. The real-time kernel is applicable to the safety-critical environment, because the source code is written in a comprehensible manner and is well documented. µC/OS-II has been applied in a wide variety of applications within safety-critical areas. The real-time kernel provides a wide range of functions: semaphores, mutual-exclusion semaphores, event flags, message mailboxes, message queues, memory management, task management and timer management.

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