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
Last Recorded Date: Aug-2015

Training CD / USB Drive

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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In July 2011, FDA published a draft guidance entitled "Mobile Medical Applications”.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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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