Understanding the Mobile Medical Applications Guidance

Instructor: Cheryl Wagoner
Product ID: 703570
Training Level: Intermediate
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

This medical device webinar will discuss the FDA guidance on Mobile Medical Applications and provide clarification on the primary points of the guidance.

Why Should You Attend:

In July 2011, FDA published a draft guidance entitled "Mobile Medical Applications”. This guidance was issued on September 25, 2013 and, though not binding, it reflects FDA’s current thinking on use of mobile applications as medical devices.

This webinar will discuss what apps are regulated by FDA under its device authority, the grey areas, the risks involved for device manufacturers and key issues that need to be addressed.

Areas Covered in the Webinar:

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

Who Will Benefit:

This webinar will provide valuable assistance to following personnel in the medical device industry:

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

Instructor Profile:

Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.

Cheryl is a member of Regulatory Affairs Professionals (RAPS), and the Association for the Advancement of Medical Instrumentation (AAMI). She completed the RAPS Executive Development Program at the Kellogg School of Management.

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