Wednesday, 29 May 2013
1:00 PM EDT / 10:00 AM PT / 17:00 UTC/GMT
Although Medical Device regulations do not enforce a fixed life cycle model, activities are presented in a sequential manner hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from Agile development methods. There’s a number of Medical Device manufacturers that have adopted Agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. AAMI’s new Technical Information Report (TIR45) gives guidance on the use of Agile in medical device development. This TIR adds new insights on the subject by mapping IEC 62304 (medical device software dev) activities into the Agile development process.
In this webcast you will learn:
- How Diagnostic Grifols has evolved its practices with this new TIR in mind
- How Diagnostic Grifols has attained significant gains in productivity with a simultaneously Agile and compliant approach.
- How this type of approach could be used in other regulated industries as well.
Jordi Manzano, R&D Instruments, Diagnostic Grifols, S.A.
Jordi Manzano has almost 15 years' systems and software development experience in the medical sector. He has worked as an engineer, project manager and currently as software quality assurance manger and deputy director of R&D at Grifols, a global healthcare company. His experience covers: in-vitro diagnostic instrumentation for immunohematology, immunology and hemostasis, medical devices for angiography and organ perfusion and devices for pharmacy compounding.
Keith Collyer, Senior Solution Manager, Electronics and Medical Devices Industry Solutions, IBM Rational Software
Dr. Keith Collyer is a Subject Matter Expert in Requirements and Systems Engineering. He trained as an electronic engineer, later moving into software development. His interest in the “people” aspects led him into project management, quality assurance and processes, never losing sight of the need to develop systems that meet real needs. Much of his career has concentrated on helping organizations large and small to introduce requirements management.
Martin Bakal, WW Offering Manager, Electronics Industry, IBM Rational Software
Marty has over a decade of experience working in various capacity's in the embedded systems and software industry with extensive customer experience worldwide in multiple industries including consumer, telecomm, medical device and automotive. He is currently the Offering Manager for the electronics industry at IBM Rational and in that role leads the initiative around that industry.
IEEE Spectrum “Tech Talk” contributor Douglas McCormick is a New York City-based freelance writer and communications consultant specializing in technology and life science. He has been editor or editorial director of such publications as PM360 (for healthcare marketers), BioTechniques (for molecular biology researchers), Pharmaceutical Technology, and Nature Publishing Company’s Bio/Technology (now called Nature Biotechnology). He was founder, CEO, and CTO of Physician Verification Services (an internet based healthcare marketing start-up) and, earlier, corporate director of scientific communications at SmithKline Beecham and computer science editor at Hayden Book Company.
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