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
Listen to FDA Director, Steve Silverman discuss the FDA Case for Quality
Podcast: How will FDASIA impact FDA Inspections?
Listen to a section of the recent FDASIA webinar, as Kathleen Culver (Field Investigator and Drug Pre-Approval Manager, FDA, Cincinnati District) discuss the impact of FDASIA on FDA Inspections:
Webinar Excerpt: How will FDASIA Impact Recalls?
View a section of the recent FDASIA webinar, as Jim O’Reilly discusses the impact of Expanded FDA Powers for Post-Market Actions:
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"Really appreciated that this was a hands on conference with so many FDA speakers and other regulators."
"Very informative. Great mix of industry personnel and FDA representation. Great opportunity to ask questions, share information and network."
"Very good network opportunity with other experts and lead resources!"
"The list of presenters/subject experts were carefully selected to include individuals that were knowledgeable with current regulatory information, articulate and personable."
