TÜV Rheinland^®

The Objective

• Gaining the right product approvals and certificates for major markets is fundamental both to success and to ensuring safety and effectiveness. Organizations need to have all the required approvals before launch of a product, as delays in obtaining them can be very costly.
• Products for use in the global healthcare markets face a range of demanding regulatory approval requirements and standards.
• Expert insight into emerging requirements and regulations, and provide services that help manufacturers understand what they need to do to ensure they have regulatory compliant healthcare products throughout the world.

Topics covered

• Introduction to Technology Assessment in the Regulatory Context: Introduction to FDA Regulations
• Safety & Effectiveness; Device Classification
• Regulatory Pathways, Premarket Notification (510(k), Premarket Approval (PMA)
• Clinical Trials and Outcome Measures; Risk Analysis
• Quality Systems Regulation & GMP
• International Regulation: Europe and Japan
• International Regulation: Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan

Dates

For your convenience we have 2 options available:

• Option 1: 7th - 9th December 2011 (Closing date 23rd November 2011)
• Option 2: 29th February - 2nd March 2012 (Closing date 14th February 2012)

Please download the registration form or click on the Register button below to find out more details and to register.
Should you need any assistance, please call us at + 65 6562 8750.