Mobile Medical Applications: Software Regulatory Requirements April 16, 2013

This mobile medical apps training will outline the regulatory requirements for medical device software development processes, and the requirements for submissions.

Why Should You Attend:

Developers of medical device cell phone / smart devices apps often find out about the relevant regulatory requirements late in the development process. Then it is very difficult to pull together what is needed to 510(k) FDA market clearance, or to create the technical file needed to get a CE Mark. In addition, most likely the app was not developed under quality system requirements.

This presentation will begin with a brief examination of the definitions and types of mobile platforms and mobile medical applications. Participants will then gain information on current FDA and European requirements for the manufacturers of mobile medical applications and guidance on a regulatory approach to these emerging applications. We will discuss requirements for the software development processes and the artifacts that should be generated during development.

This session will answer all of the following:

- When is a mobile app a medical device?
- What medical device regulations / standards apply to the development of mobile medical apps?
- What should I do, while developing the software, to create what is needed for an FDA submission or an EU technical file? What software development artifacts do I need to have?
- My app is developed and I have no artifacts. How do I get a 510(k)?

Official Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702812?channel=yahooevent