MEDCON 2014

Hear the most current regulations and legislation affecting the Medical Device Industry, delivered directly from the FDA and Industry experts. Interact with FDA Directors and field investigators to discuss topics such as:

• The FDA Safety and Innovation Act: New requirements and FDA Expectations

• The Case for Quality Initiative: How will this impact you?

• The new 510(k) and PMA guidances, new MDUFA III requirements, the Presubmission Program, QSIT, and top priorities of the ODE

• Tips on how to prepare for the Unique Device Identification final ruling

• A Total Product Lifecycle Case Study by the FDA focusing on Post-Market Surveillance, Risk Management, CAPA, and Design

Why Attend MedCon?

Through dynamic, lively discussion and in-depth presentations, you’ll enhance your ability to navigate the global medical device market with topics such as:

• The new EU regulations and how you can implement compliance in your company

• The essentials for acquiring a CE Mark

• Successful Global Product Strategy, including product entry in Central and South American Markets