Cert-kit simplifies standard-compliant development of medical products

Comprising all the elements required for creating an executable application, the Cert-Kit includes a 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 IEC62304 standard defines the life cycle requirements of software in medical products, and 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, thus saving time and money for the customer.

µC/OS-II is a portable, ROM-capable, scalable, pre-emptive, deterministic real-time kernel for microprocessors, microcontrollers and DSPs. It is used in many different industries. The real-time kernel is particularly popular in the safety-critical environment, because the source code is written in a comprehensible manner and is well documented. µC/OS-II has proven itself 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.

“Rapid technological progress, the exacting safety requirements and the enormous pressure on prices in medical technology necessitate a consistent implementation of the restrictive development and manufacturing processes in accordance with IEC62304. The certification of safety-relevant systems for medical applications is however a complex and lengthy process”, commented Thomas Amann, Managing Director of Embedded Office. “With our new µC/OS-II Cert-Kit, we are offering a solution that caters to the process requirements defined by IEC62304 and which simplifies the certification process.”

The test environment is avialable on request. Functional safety during the project implementation phase is ensured at Embedded Office by the Functional Safety Engineer Wolfgang Engelhard (TÜV FS Eng 4424/11).