IEC 62304 Compliance: Recognizing Risks and Closing the Gaps

Duration: 1 hour


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 device industry.

Speaker biographies:
Chris 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 carpenter.

Dan Goldman, Systems Architect, Foliage, Inc.
Yi Zheng

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.

About QNX Software Systems

QNX Software Systems Limited, a subsidiary of BlackBerry, is a leading vendor of operating systems, development tools, and professional services for connected embedded systems. Global leaders such as Audi, Cisco, General Electric, Lockheed Martin, and Siemens depend on QNX technology for vehicle infotainment units, network routers, medical devices, industrial automation systems, security and defense systems, and other mission- or life-critical applications. Founded in 1980, QNX Software Systems Limited is headquartered in Ottawa, Canada; its products are distributed in more than 100 countries worldwide. Visit and, and follow @QNX_News on Twitter.

About Foliage

Foliage, Inc., a product development company, partners with companies to address the business and technical challenges inherent in developing complex software‐intensive systems. By providing a full complement of engineering and consulting services aligned to business needs and applied over the entire product lifecycle, Foliage enables companies to accelerate development and drive more predictability and productivity into their businesses. Foliage leverages over 20 years of experience partnering with leading companies in the Medical and Life Sciences, Aerospace and Defense, and Industrial Equipment industries. Working with Foliage, companies gain the critical insights necessary to develop products with a difference, and to deliver the products their customers want, when they want them. Foliage is based in Burlington, Massachusetts with additional offices in California, the Netherlands and India. For more information, visit


Register now for this on demand webinar: IEC 62304 Compliance: Recognizing Risks and Closing the Gaps