ComplianceOnline

Is Device Registration and Listing Stressing You Out?

Instructor: Cheryl Wagoner
Product ID: 703571
Training Level: Intermediate
  • Duration: 60 Min

recorded version

$229.00
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

Training CD

$299.00
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

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will provide clarification on which medical device facility or establishment must register and list, how to register and list, and how to coordinate the payment process to accomplish the actual registration or device listing.

Why Should You Attend:

There is no current guidance available on device registration and listing. Though there is much information on the FDA website about who must register and list, how to register and list, it can all still be a bit confusing to coordinate the payment process with accomplishing the actual registration or device listing.

During this 60-minute webinar, the speaker will provide key information and practical knowledge that will help you to sort through the confusion and have your medical device facility or establishment registered and product listed.

Areas Covered in the Webinar:

  • Background of the device registration and listing
  • How does registration and listing relate to MDUFMA?
  • What is FURLS?
  • Who must register and list?
  • When are you required to register and list?
  • How do you register and list?
  • How do you pay your annual fee for registration?v
  • Do you need a US Agent? If so, what are the responsibilities of the agent?

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
  • Documentation
  • Senior Management
  • Finance

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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