|
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, TV 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.
|
|
