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
- $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
- 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
- Click here for the Full Agenda
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