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Pre and Post Conference seminars
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Software Development for Medical Devices
Many medical device manufacturers find it difficult to develop software in compliance
with FDA QSR regulations and international standards such as ISO 14971, ISO 13485,
ISO 62304 and other emerging standards. This two-day workshop provides your organization
with practical guidance and recommendations for a software development process that
complies, is flexible, cost-effective and makes good business sense.
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Our training includes:
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Benefits:
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Introduction
Interpreting Design Controls for Software
Software Verification Process
Software Validation Process
Risk Management for Software-based Medical Devices
Validation of Software Tools Used to develop Device software
Validation of Software Used in Manufacturing and Quality Systems
Summary
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This two-day seminar focuses on interpreting FDA Regulations and Standards for Medical
Device Software.
Specifically, the course includes a comprehensive discussion of Design Controls,
interpreted for medical device software.
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Steven R. Rakitin has 30 years experience as a software engineer and software
quality manager in a broad range of industries. He has written several papers on
the subject of software quality and published a book titled: Software Verification
& Validation for Practitioners and Managers. He was a member of the Working Group
that produced the first IEEE Standard for Software Quality Assurance Plans (IEEE-STD-730).
He is currently serving on the IEEE Standard 1012 (Verification & Validation) Working
Group. He received a BSEE from Northeastern University and an MSCS from Rensselaer
Polytechnic Institute. He has earned certifications from the American Society for
Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He
is a member of the IEEE Computer Society, the ASQ Software Division, and is on the
Editorial Review Board for the ASQ Journal Software Quality Professional. He presents
tutorials and workshops at conferences worldwide. As President of Software Quality
Consulting Inc., he helps companies establish a more predictable software development
process.
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WHEN:
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October 21-22, 2010 |
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WHERE:
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Best Western Royal Plaza
Marlborough, MA |
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Course Code:
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107 |
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TIME:
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9:00 am to 5:00 pm |
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TO REGISTER PLEASE VISIT OUR WEBSITE.
NEQC Administration, Phone: (508) 987-3800 Fax: (508) 987-1464
E-mail: Registration@neqc.org
Website: www.neqc.org
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