Understanding the Mobile Medical Applications Guidance 2015

Topics

• Define mobile platforms, mobile app, mobile medical app
• Background of the guidance
• Examples of mobile apps that are not medical devices
• When is a mobile app also a medical device?
• Regulatory approach
• Examples of mobile apps that are medical devices
• Regulatory requirements

Who should Attend

• Project managers
• Regulatory affairs
• Product Development managers
• Staff involved with regulatory filings
• Scientists
• Mobile and Smartphone Companies
• Research Analysts