Solution Briefs and Overviews

Developing Reliable Medical Devices with Confidence

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DEVELOPING RELIABLE MEDICAL DEVICES WITH CONFIDENCE Regulatory approval of VxWorks Cert Edition for IEC 62304 strengthens opportunities for innovation and streamlines design cycles WIND RIVER SOLUTION BRIEF Regulatory Approval of VxWorks for Medical Applications 1 WHY IEC 62304 MATTERS The IEC 62304 standard spells out the compliance requirements for software used in medical devices. This standard has been widely adopted by regula- tory bodies in the Americas and Europe, as well as within other jurisdictions. To release medical devices to market, OEMs and medical device manufacturers must adhere to the requirements. Having a medical grade OS—VxWorks Cert Edition—at the heart of a product is a major step toward achieving the neces- sary regulatory approval to compete successfully in this market sector. KEEPING PACE WITH THE CHALLENGES IN MEDICAL SOFTWARE DEVELOPMENT Developing effective, compliant software for medical devices requires a bal- anced 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 require- ments 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 medi- cal devices based on a real-time operating system (RTOS) built by Wind River, a company with long-standing expertise in secure embedded solutions, con- fers 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 prod- uct'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 enter- prise-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.

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