Overview

With the growing complexity of today’s medical devices, regulatory scrutiny is becoming increasingly stringent. Choosing a pre-qualified component with a known pedigree can significantly aid in the qualification process. The QNX OS for Medical is assessed by an independent third party to be compliant with IEC 62304, a standard for "Medical device software – Software life cycle processes". The product is supported on ARM and x86 processors.

The QNX® OS for Medical is a key component of QNX Software Systems’ solution for medical device manufacturers. It is designed to help medical customers meet stringent regulatory requirements by reducing the time and effort needed in pre-market qualification activities. The QNX OS for Medical is 100% API-compatible with QNX’s standard operating system, allowing customers to maximize software re-use and making it possible to build a common platform for multiple products with different qualification requirements. The product is shipped with the independent third-party assessed declaration of compliance to IEC 62304 Class C.

  • Reduces pre-market certification efforts and costs
  • Accompanied by an IEC 62304 Declaration of Compliance
  • Fully API-compatible to other versions of QNX Neutrino, eliminating porting efforts
  • Fully integrated with QNX Momentics, QNX Screen, and Qt graphics technologies
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Product in Action

Solution

QNX medical solution

Understanding the challenges medical customers face with regulatory requirements, QNX Software Systems offers a variety of services to help customers with their qualification activities. Customers can choose any number or combination of these services based on their specific needs. These services include:

  • Training course on designing and architecting safe and dependable systems
  • On-site audit during certification assessment
  • Subject Matter Expert consultancy offering

Visit the QNX Medical Solutions page for more information.

Benefits

  • IEC 62304 Class C compliance documentation set simplifies the manufacturers Safety Case
  • 100% API-compatible with QNX OS
  • Fully supports other QNX and partner middleware stacks
  • Support for connectivity choices including Ethernet, USB, Bluetooth Classic and Low Energy
  • Broad partner ecosystem