This 90-minute webinar will help you understand the current landscape of the growing field of mobile medical applications and the current regulatory efforts to ensure that the related medical devices will not pose high risks for patient safety and promote innovations.
All functional groups who have medical device responsibility or need to understand the basics of mobile medical applications for medical devices and smartphones will benefit by attending this training.
Why Should You Attend:
This webinar will begin with an overview of mobile applications in the health industry, and focus on medical devices related to mobile health. It will then review the new and expected regulations - the 2011 FDA draft guidance in mobile medical apps and the FDA Safety and Innovation Act - and discuss their effects on the use of mobile medical application for devices. We will explain what the policies are, predict coming regulations and discuss how industry will be affected. We will explore the current mobile health landscape in US and globally.All functional groups who have medical device responsibility or need to understand the basics of mobile medical applications for medical devices and smartphones will benefit by attending this training.
Areas Covered in the Seminar:
- Overview of Health IT and mobile industry.
- Basic of mobile applications for health.
- Medical devices related to mobile health.
- Draft guidances in mobile medical apps(FDA 2011).
- FDA Safety & Innovation Act confirms role in mobile field.
- Patient and Consumer health information and security.
- Coming FDA final guidelines and DHHS actions.
- Mobile health standards.
- Mobile Health globally(WHO).
Who Will Benefit:
- Senior Management
- New medical devices project leaders & members
- Regulatory affairs
- Quality systems personnel
- R&D and engineering staff
- Information Security Officers
- Risk Managers
- Compliance Officers
- Privacy Officers
- Health Information Managers
- Information Technology Managers
- Medical Office Managers
- Systems Managers
- Legal Counsel
- Operations Directors
- Medical offices, hospitals, academic medical centers, insurers, business associate
- All related to risk analysis/management, regulatory submissions, and validations
Course Provider
Kosta Makrodimitris,
