Developing Reliable Medical Devices with Confidence

KEEPING PACE WITH THE CHALLENGES IN MEDICAL SOFTWARE DEVELOPMENT

Developing effective, compliant software for medical devices requires a balanced blend of regulatory awareness, proven components, and efficiency of design practices. Wind River® addressed each of these factors in the latest release of VxWorks® Cert Edition. Engineered with medical-grade requirements in mind, VxWorks Cert Edition meets regulatory approval for the IEC 62304 standard, combining strong, built-in security; well-defined software lifecycle processes; and careful attention to the constraints that govern the classification and use of medical devices.

Development teams are keenly aware of the trade-offs involved when dealing with time, cost, and regulatory mandates that affect projects. Building medical devices based on a real-time operating system (RTOS) built by Wind River, a company with long-standing expertise in secure embedded solutions, confers numerous benefits. These benefits have been demonstrated across a diverse portfolio of projects completed to rigorous standards for aerospace, defense, and the medical sector. Having a solid RTOS at the heart of a product’s hardware/software stack removes much of the uncertainty from the design and can streamline updates, improving on prior manual processes. Other benefits include dynamic network device management and enterprise- caliber security provisions. A widespread, supportive ecosystem and industry-wide familiarity with the tools and components of the VxWorks Cert Edition platform gives assurance to device manufacturers that want proven, field-tested technologies.