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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. |
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