IEC 62304 Compliance: Recognizing Risks and Closing the Gaps
In this webinar, attendees will learn about the
new process requirements that are a result of IEC 62304, as compared to FDA
guidance requirements, and examples of common development process gaps that can
arise when moving an existing process to become IEC 62304 compliant. We will
focus on the software risk management requirements of IEC 62304, and the
different process steps required when developing software of each of the
different safety classifications. The business impact of the process
requirements will be briefly reviewed.
Having different levels of safety
classification in your software offers challenges and opportunities when
architecting the entire system. There are options and best practices available
for delivering a system solution that has different levels of safety
criticality. The options that will be discussed include no separation, hardware
separation, multicore, and software separation techniques. The difficulty of
implementation of the chosen strategy is affected by choices of operating system
and other third party tools which can impact your verification, validation,
certification and approval processes.
Join this webinar to learn these
best practices and listen to the experts that have architected the software
subsystems of many medical devices, all of which have gained IEC 62304
compliance and FDA approvals.
Estimated length: 1 hour, including
Q & A.
Who should attend:
This seminar is best
suited for software engineers and managers who are involved in the medical
Ault, Product Marketing Manager, QNX Software Systems
Chris Ault is
the product manager responsible for QNX Software Systems’ medical product
portfolio, which includes the QNX Neutrino RTOS for medical devices. Before
joining QNX, Chris was a senior product manager focused on virtualization
technologies. Prior to this assignment, he held positions of increasing
responsibility with hardware and software vendors, including Ciena, Nortel,
Catena Networks and Liquid Computing.
Chris holds degrees in computer
science, electronics, and economics from Algonquin College and Carleton
University. He is an avid electric guitar player and water skier, and a skilled
Goldman, Systems Architect, Foliage, Inc.
As a lead medical device
system architect at Foliage, Dan Goldman focuses on the development of complex
medical devices of various classifications including life-sustaining devices,
patient monitors, and large hospital laboratory instruments. Since joining
Foliage in 2004, Dan has been influential in the evolution of the company’s
product development processes especially in the areas of system and software
development. From the beginning of his career in 1987, Dan has designed
safety-critical embedded systems; including nearly 20 years’ experience in
medical device development. Dan holds a Master’s degree in Electrical
Engineering from the University of Texas at Arlington and a Bachelor’s degree in
Electrical Engineering from Purdue University.
Please disable any pop-up blockers for proper viewing of this webinar.