BlackBerry's QNX today announced a new release of its software platform for medical devices that is now IEC 62304-Compliant. The QNX OS for Medical 1.1 is based on QNX OS technology field-proven in an array of systems for angiography, proton therapy, laser eye surgery, hemodynamic monitoring, and other critical healthcare applications. The OS supports both single-core and multi-core devices based on ARMv7 and Intel x86 processors, and it offers API compatibility with other members of the QNX OS family, enabling a high degree of software re-use.

"When it comes to medical device software, the OS sets the tone: unless it provides the architecture to enable reliable operation and a clear audit trail to substantiate claims about its dependability, the entire process of device approval can be put in jeopardy," said Grant Courville, director of product management at QNX Software Systems. "By providing an OS that has been independently verified to comply with the IEC 62304 standard, we are helping manufacturers reduce the cost and effort of developing devices that require regulatory approval from agencies such as the FDA, MDD, and MHRA."

QNX OS for Medical 1.1 is available now and is a component of QNX Software Systems' broader medical offering, which includes proven-in-use data, hazard and risk analyses, on-site audits, training courses in safe design, and professional engineering services. Customers can also choose from a rich of complement of QNX technologies.

Press Release

QNX Releases New Version of IEC 62304-Compliant OS for Medical Devices

Helps manufacturers reduce cost and effort of developing devices that require regulatory approval from agencies such as the FDA, MDD, and MHRA.

OTTAWA, July 15, 2014 — Building on its proven history of providing highly reliable software platforms for safety-critical environments, QNX Software Systems Limited, a subsidiary of BlackBerry, today announced a new release of its OS for medical devices.

The QNX® OS for Medical 1.1 complies with the IEC 62304 medical device standard for software life cycle processes and is designed to help manufacturers reduce the cost of developing robotic surgical instruments, patient monitoring systems, infusion pumps, blood analysis systems, and other safety-critical products that must pass stringent regulatory approval.

"When it comes to medical device software, the OS sets the tone: unless it provides the architecture to enable reliable operation and a clear audit trail to substantiate claims about its dependability, the entire process of device approval can be put in jeopardy," said Grant Courville, director of product management at QNX Software Systems. "By providing an OS that has been independently verified to comply with the IEC 62304 standard, we are helping manufacturers reduce the cost and effort of developing devices that require regulatory approval from agencies such as the FDA, MDD, and MHRA."

The QNX OS for Medical 1.1 is based on QNX OS technology field-proven in an array of systems for angiography, proton therapy, laser eye surgery, hemodynamic monitoring, and other critical healthcare applications. The OS supports both single-core and multi-core devices based on ARMv7 and Intel x86 processors, and it offers API compatibility with other members of the QNX OS family, enabling a high degree of software re-use.

The QNX OS for Medical 1.1 is a component of QNX Software Systems' broader medical offering, which includes proven-in-use data, hazard and risk analyses, on-site audits, training courses in safe design, and professional engineering services. Customers can also choose from a rich of complement of QNX technologies, including:

  • Flexible user interface technology that can blend together applications and components created with the Qt framework, HTML5, OpenGL ES, Crank Storyboard, video, and other sources.
  • The QNX® Momentics® Tool Suite, an Eclipse-based development environment with profiling tools designed to help developers gain maximum insight into software behavior.
  • A wide range of processors, protocols, and tools available through the extensive QNX partner ecosystem.

Availability

The QNX OS for Medical 1.1 is available now.