MD Review - Medical Device Risk Management Seminars  
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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
Sherman Eagles Sherman Eagles

Your Hosts
Alf Dolan Alf Dolan
Stan Mastrangelo Stan Mastrangelo

  About Your Hosts           

Alf Dolan

Alf Dolan is the Samuel Lunenfeld Professor of Clinical Alf DolanEngineering 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 MastrangeloStan 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. Sherman Eagles 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.


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.

Virginia Tech