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.