It’s not an option. If you have software in a medical device, it must have been developed using processes compliant with the IEC 62304 software life cycle standard. That much is clear, but what actually constitutes conforming to the regulation is not as concrete. The IEC 62304 standard merely states that the software development processes must be as good as, or better than, what is required in the IEC 62304. That leaves some room for interpretation and perhaps making the wrong choices, leaving you on the wrong side of “is as good as” and well behind where you need to be in bringing the device to market.
This webinar will discuss the software development activities that you need to include in your process and the deliverables you need to create to ensure that you meet the IEC 62304 standard with a minimum of headaches and a high level of employee compliance.
The following topics will be covered:
• An overview of IEC 62304
• Critical implementation issues
• Keys to a successful implementation
• How to reconcile an iterative software development approach with 62304
Tim Stein, Ph.D.
CEO and President
Business Performance Associates, Inc.
Tim founded Business Performance Associates, Inc., a consulting firm located in Cupertino, California, in 1994. Tim has consulted with over 100 companies of all sizes. Tim’s major services include: software development regulatory compliance, software validation, and implementing quality systems. Tim has helped numerous companies achieve compliance with IEC 62304 through gap analyses, training and implementation support.
Tim was the Director of Software Validation and Quality Assurance at Genomic Health. He is the author of the: The Computer System Risk Management and Validation Lifecycle.
Dan has worked for more than 30 years in regulated environments both with the DoD and the FDA. The companies he has worked for include Boston Scientific, Abbott Hematology and Oraya Therapeutics, His understanding of 62304 implementation issues comes from years in software development as a manager of engineers who developed medical device software using 62304 compliant procedures, and also as a Software Engineer, Team Lead and Principal Architect on small and large software development projects encompassing the entire Software Development Lifecycle.
Dan has a B.S. degree in Biological Sciences from the University of Hawaii and holds 13 patents
Analyst at Cientifica, a business intelligence company for emerging technologies
Author and Editor of several market reports on nanotechnology
Contributing editor for IEEE Spectrum’s Tech Talk
Program Director for numerous international conferences on nanotechnology, fiber optic
Who should attend:
• System Engineers
• Software Engineers
• Product Development
• Research & Development
• Quality Assurance
• Regulatory Affairs"
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