Software: The Evolving World of Medical Devices

Software: The Evolving World of Medical Devices is a workshop that provides practical guidance for regulatory, quality, product design, engineering, and business professionals. Speakers from FDA and industry will cover a range of topics from the current guidance and techniques through software-related standards from groups like IEC TSC 62A, ISO TC 210, ISO TC 215, and HL7. Assurance cases and the Team Software Process (TSP), US & International regulations on Health IT, and mobile apps will also be covered in this can’t miss updated software seminar.

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Who Should Attend

• Regulatory
• Quality
• Product Design
• Engineering
• Business ProfessionalsAdvaMed Office's

Registration

• $595.00 AdvaMed EGC Member Registration (< $30 Million gross sales)
• $0.00 AdvaMed Staff Registration
• $1,295.00 AdvaMed Member Registration
• $1,595.00 Non-Member Registration
• $0.00 Speaker Registration
• $595.00 Government and Non-Profit Registration

Agenda Overview

• Software guidance and standards: Past, Present, and Future
• Present: Panel Discussion of Limitations/gaps with Existing Standards/guidance
• Future: Update on Current Software Standards Activities
• US and International Regulations of Health IT – Presentations/Panel Discussion
• Mobile Apps

Part 11 – Where Is It, and What Should Companies Be Doing About It?

• The View from the Hospital Side
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Speakers

• Phillip J. Phillips, President, Phillips Consulting Group, LLC
• Sheri Hall, Vice President, Regulatory Affairs, BD 
• Marjorie Shulman, Consumer Safety Officer, Pre-market Notification Staff, FDA/CDRH
• Dr. David Buckles, Ombudsman, FDA
• David L. West, PhD, MPH, Vice President, Medical Device Development, Quintiles Consulting 

Click here for the Full Agenda