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.
1 hour, including Q & A.
This seminar is best suited for Software engineers and designers, Hardware engineers and designers and System architects and engineers.
Nataliya Gencheva has spent the last 8 years working in a variety of roles with the Telecommunications industry. Six of those past years have been with Deutsche Telekom AG. She has been in her current role as International M2M Partner Development Manager since the establishment of DTAG's M2M Competence Center in 2010. Ms Gencheva is responsible for a broad portfolio of horizontal partners ranging from multinational corporations through SME and Start-ups. In addition to her role at DT, Ms Gencheva is also a Mentor for Berlin Geekettes.
Steve West is responsible for extending the success of new product and service innovation at BlackBerry. Mr. West is actively driving the proliferation of BlackBerry technology with a vision for it to be the foundation for connected computing platforms on a broad scale, across a number of vertical industries.
Prior to joining BlackBerry, Mr. West was the VP of Emerging Technology and Media for Alcatel-Lucent where he drove the success of the ng Connect Program, a vibrant multi-industry eco-system to foster broad industry adoption of ultra-high bandwidth technologies such as 4G and the next generation user experience it enables.
Mr West also has a long history in telecom and high tech where he has been responsible for consumer broadband services development and marketing. Mr. West holds a Diploma in Marketing and International business from St. Mary's University in Halifax, NS, and a Diploma in Electronic Engineering Technology.
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 http://www.qnx.com and http://www.facebook.com/QNXSoftwareSystems, and follow @QNX_News on Twitter.
Deutsche Telekom is one of the world's leading integrated telecommunications companies with more than 132 million mobile customers, over 32 million fixed-network lines and 17 million broadband lines (as of December 31, 2012). The Group provides products and services for the fixed network, mobile communications, the Internet and IPTV for consumers, and ICT solutions for business customers and corporate customers. Deutsche Telekom is present in around 50 countries and has 230,000 employees worldwide. The Group generated revenues of EUR 58.2 billion in the 2012 financial year – more than half of it outside Germany (as of December 31, 2012).
Register now for this on demand webinar: Overcoming the Challenges with M2M Device Lifecycle Management