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»MD Review
Upcoming Seminars
The New Landscape of Usability and Human Factors Issues for all Medical Devices
Date/Time: TBA
Current International Thought on Software Development - A Life Cycle Approach
Date/Time: TBA
A Review of Enterprise Risk Management and ISO 31000 for Pharmaceutical and Medical Device Companies
Date/Time: TBA
Featured Speaker
Your Hosts
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About Your Hosts
Alf Dolan
Alf Dolan is the
Samuel Lunenfeld Professor of Clinical
Engineering
at the University of Toronto.
He is also a COTA
Fellow at
Virginia Tech. Convener of the Joint IEC/ISO Working Group on
Application of Risk Management to Medical Devices, and member of
numerous medical risk management and standardization advisory boards.
Mr. Dolan has contributed to the publication of
Standard ISO 14971-1 and two
editions of ISO 14971: Risk
Management for Medical Devices, which is the world wide standard in
this area for medical devices.
Stan Mastrangelo
Stan Mastrangelo is a Professor of Clinical
Engineering at Virginia Tech. Quality assurance professional with over
25 years of industry experience, including management of Quality
Engineering and Director, QA Operations, Medical Devices. Active
participant on the ANSI Executive Standards Council, ISO/IEC 14971 Risk
Management for Medical Devices, and PhRMA team for ICH Q9 Pharmaceutical
Risk Management. Mr.
Mastrangelo is also a skilled educator with significant broadcasting
experience, a definite asset for MD Review.
Sherman Eagles
Sherman Eagles is a Technical Fellow at Medtronic, Inc.
He has been at Medtronic for 17 years working on software development, software process, software safety and software reliability in medical devices.
He is currently a member of the Quality Pre-release Department in Medtronic’s
Cardiac Rhythm Disease Management division working on Software Dependability and Safety.
He has nearly 40 years of software experience,including development work on operating
systems, communications systems, software development tools and software development processes.
Sherman is chair of the medical device software working group of AdvaMed and represents AdvaMed
on the Global Harmonization Task Force (GHTF) software committee. He is a co-chair of the
Medical Device Software Committee of The Association for the Advancement of Medical Instrumentation (AAMI).
He is the convener of three international standards working groups responsible for safety requirements
for programmable electrical medical systems, medical device software life cycle processes, and
risk management for IT networks that include medical devices. He received a Bachelor’s degree
in physics from Macalester College.
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MD Review Audio
Learning Seminars are Sponsored by
Virginia Tech's
Center for Applied Health Sciences.
www.cahs.vt.edu
The Center for Applied Health Sciences is dedicated to the
advancement of risk management through graduate education,
seminars and workshops, and targeted learning opportunities
for corporations, regulatory agencies, and professional
groups in the food and healthcare industries.
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