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
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.
This seminar is best suited for software engineers in the
medical devices and safety-critical embedded market.
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.
Hobbs, Senior Developer – Safe Systems, QNX Software Systems
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).
Please disable any pop-up blockers for proper viewing of this webinar.