The complexity of medical devices continues to increase at an astounding rate. From high-precision robotic surgery to 3D printing of artificial organs, the possibilities seem limitless. As a trusted operating system provider for medical devices, BlackBerry QNX has had a front row seat at this amazing evolution in medical device technology. BlackBerry's QNX OS for Medical 2.0 is a reliable, multi-core, real-time operating system (RTOS) that is POSIX compliant for building safety-critical embedded systems for the medical market, supported by field-proven development tools, feature-rich middleware, and professional services.

QNX® Neutrino® RTOS, the core of QNX OS for Medical, has been successfully deployed in hundreds of safety-critical applications across many different fields, including nuclear power plants, high-speed rail, industrial automation, and surgical equipment. The Neutrino® RTOS derives its reliability from the unique microkernel architecture and carefully-designed separation mechanisms such as Adaptive Partitioning. It is also designed to help reduce the e ort involved in building safety-critical products that must pass regulatory approvals. Choosing components that are already compliant, and have a credible pedigree, can significantly speed up the device certification process.

Benefits Safety standards compliance to reduce risk, development time, and certification cost The QNX OS for Medical is compliant for use in applications requiring up to Class C IEC 62304 compliance, a standard for “Medical device software – Software life cycle processes”. It has been assessed by a reputable auditing body, TÜV Rheinland, thereby helping medical device manufacturers solve the problem of qualifying “SOUP” (Software of Unknown Provenance).

By supporting the needs of medical device manufacturers, BlackBerry QNX helps reduce program cost and risk, and shortens the time-to-market for medical device developers. The product is assessed by an independent third-party auditing firm to IEC 62304 Class C, the highest class for applications where death or serious injury is possible. IEC 62304 is a standard that has been endorsed under medical device-related directives by the FDA in the U.S. and by the Directorate-General for Health and Consumers in the EU, enabling manufacturers to follow good development practices and to produce high-quality software for medical applications.

Services

To complement QNX OS for Medical, QNX Professional Services provide cost-effective assistance and expertise to medical device manufacturers for developing highly reliable embedded software and meeting regulatory agency requirements.

Examples of services include:

• Training
• Architectural reviews
• Custom engineering