ComplianceOnline

Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity

Instructor: Edwin Waldbusser
Product ID: 705432
  • 30
  • November 2017
    Thursday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 60 Min

Live Online Training
November 30, Thursday 10:00 AM PST | 01:00 PM EST | Duration: 60 Min

$199.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD free!

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD

$349.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD

$449.00

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.

Why Should You Attend:

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than just testing performance.

Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app design will be explained.

Areas Covered in the Webinar:

  • What mobile apps are medical devices
  • What mobile apps will be regulated by FDA
  • How to get a mobile app approved by FDA
  • Cybersecurity for mobile apps

Who Will Benefit:

  • Engineering Manager
  • Regulatory Personnel
  • Development Engineers
  • Production Management
  • QA/QC Personnel
  • Software Developers
  • Usability Engineers
  • Risk Managers
  • Design Engineering Managers
Instructor Profile:
Edwin Waldbusser

Edwin Waldbusser
Regulatory Consultant, Med Device Advisors

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

Follow us :
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
Computer System Validation - Reduce Costs and Avoid 483s

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.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading