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Course Description:

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.

Learning Objectives:

After completion of this two day interactive course on IVD, the attendee will be able to:

  • Understand why IVD is regulated differently.
  • An overview of IVD Regulations – U.S. FDA., Europe (MDD), Canada.
  • Develop Regulatory Strategies and determine Regulatory Pathways.
  • Inclusion and exclusion of data and information for different submission.
  • Format and Content of premarket submissions.
  • Product Label and Labeling for IVDs.
  • Working and interacting with the reviewers and regulators.
  • Tips and Suggestions to secure rapid regulatory approvals.

For Registration

Note: Use coupon code 232082 and get 10% off on registration.

Contact the event managers listed below for more information about how you can participate at the Navigating through Maze of In-vitro Diagnostics (IVD) Regulations.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Conference/Event Dates: 04/16/2015 - 04/17/2015
Conference/Event Hours: 8:30 AM - 4:30 PM EDT
Classification: B2B
Primary Industry: Medical Technology
Other Industries: Manufacturing, Medical, Medical Technology, Professional Healthcare
Estimated Attendance: 30
Cost to Attend: Seminar One Registration - $1299
Audience: Department Managers (middle management)
Research & Development (R&D)
Product Design & Development
Validation Engineering
Regulatory Affairs
Quality Assurance
Quality Control
Venue: Courtyard Newark Downtown
Venue Phone: (973) 848-0070
Venue Type: Indoor - Hotel
Show Owner:ComplianceOnline

Booth Size Booth Cost   Available Amenities
No exhibiting at this event.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

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Navigating through Maze of In-vitro Diagnostics (IVD) Regulations

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