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1st Edition  Conference

Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada


"Product Label and Labeling for IVDs"
In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada.This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.


Highlights

  • Why the regulators need separate regulations even IVD is considered a device?
  • Know the process and players at OIR (aka OIVD) of CDRH and Health Canada
  • Understanding of EU MDD 98/79/EC for IVD and applicable MEDDEV documents
  • Understanding similarities and differences between U.S. and Europe regulations
  • Format and Content of Canadian Medical Device License (MDL) Application

Timings

8:30 AM - 4:30 PM (Oct 14) (General)
8:30 AM - 4:30 PM (Oct 15) (General)

Entry Fees

Paid Ticket Starts from 1899 USD View Details

Participants

20
Delegates

5 Exhibitors Estimated Count

Category & Type

Conference
Science & Research
Education & Training

Editions

14-15 Oct 2019 Interested


Frequency Bi-annual

Official Links

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ComplianceOnline USA

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Sheraton Boston Hotel

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