Which OS for IEC 62304 Medical Devices?
As medical devices become increasingly complex and connected, focus on patient safety, data, and security are all causing increasing scrutiny from regulatory bodies. The ongoing quest by regulatory bodies to work with industry to achieve fewer device recalls and greater safety assurance seem to be at odds with recent evidence of increased adoption of Linux for the underlying platform. The fundamentals of the impact of "move fast and break things-stabilize over time" development approaches, combined with inherent fact that one cannot "test quality into software" are discussed in a practical manner.
This webinar is about choosing an embedded OS for medical devices—or indeed any system where reliability, recovery and safety are critical differentiators. It directly examines the fundamental software development cycle, which IEC 62304 dictates shall include risk analysis and mitigation, and the cost of meeting those challenges over the entire lifecycle, which device manufacturers can use to evaluate OSs they are considering for their remote-care medical devices. We examine how a properly architected and implemented purpose-built OS (RTOS) is needed in any system where safety, stability and long-term lower cost of ownership are a concern. The choice of OS can have a significant impact all of these factors.
Attendees will learn about critical differences, from the standpoint of software stability, safety and the risk mitigation goals of IEC 62304/ISO 14971, between stable, purpose-built, real-time operating system platforms and more volatile, general-purpose, open source operating systems platforms, such as Linux. An overview of specific aspects of IEC 62304/ISO 14971 intended to lower risk of failure in medical devices will be contrasted with the practical realities of the fundamental ways in which the large-scale general-purpose open source Linux project is developed versus more stable, purpose-built, safety-certified embedded operating systems, will be examined. We will discuss specific characteristics medical device manufacturers should look for in the OSs they are considering for their products, and how the choice of OS can significantly impact total project cost over the lifetime of the project.
Who should attend:
This seminar is best suited for software engineers in the medical devices and safety-critical embedded market.
Chris Ault, Product Marketing Manager, QNX Software Systems
Chris Ault is a product manager focusing on the medical and general embedded markets. Prior to joining QNX, Chris worked in various roles, including software engineering, engineering management, product management, and technical sales, at AppZero, Ciena, Liquid Computing, Nortel, and Wind River Systems.
Chris Hobbs, Senior Developer - Safe Systems, QNX Software Systems
Chris Hobbs is a kernel developer at QNX, specializing in "sufficiently-available" software: software created with the minimum development effort to meet the availability and reliability needs of the customer; and in producing safe software (in conformance with IEC61508 SIL3).