MedCon Featured Topics
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
2013 MedCon Conference Deliverables
Review our 2013 conference presentations
Review 2013 Session Recaps
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:
19 FDA Representatives
Abruzzo Regulatory Affairs Consulting, LLC
Advanced Sterilization Products
Americas Blood Centers
Biotechnology Consulting Solutions, Ltd.
Carestream Health, Inc.
CIBA Vision / Alcon Labs
Cincinnati Children’s Hospital Medical Center
Cincinnati USA Chamber
Cleveland HeartLab, Inc.
Clin Biochem Consulting
Clinical Research Consultants, Inc.
ConneXion LifeSciences LLC
Cook Group Incorporated
Device & Implant Innovations LLC
Devicor Medical Inc.
DiaPharma Group, Inc.
DuVal & Associates, P.A.
E-BEAM Services, Inc.
Eagle Creek Engineering
Expert Medical Device Consulting, Inc.
Faegre Baker Daniels
Flanders Investment and Trade
Flynn Consulting Services
Gold Thread LLC
Hitachi Medical Systems America
IHL Consulting Group
IMARC Research Inc.
Johnson & Johnson
King & Spalding LLP
Krafft Consulting Intl LLC
Life Science Innovation, LLC
McGuire VA Medical Center
McNeil Consumer Healthcare
Meridian Bioscience Inc
MiraVista Diagnostics, LLC
Mound Laser & Photonics Center
Neil Burris & Associates
Orthopedic Generations LLC
Pew Charitable Trusts
Plus Pillow, Inc.
Procter & Gamble
Quality System Architects
Regulatory & Quality Solutions
Regulatory Compliance Associates
Saudi Food & Drug Authoritey
Sensors for Medicine and Science
Small Business Administration
SNS Nano Fiber Technology, LLC
St. Jude Medical
Strategic Regulatory Partners, LLC
Sybron Dental Specialties
The Gray Sheet
The Health Foundation
The Mastery Institute
The Silver Sheet / Elsevier
Thermo Fisher Scientific Inc.
U.S. Department of Commerce
U.S. Senate Committee on Health, Education, Labor
U.S. Senator Rob Portman
US Patent and Trademark Office
Vascular Devices, LLC.
West Chester Township
X-spine Systems Inc.
Thank you to our 2013 Sponsors!
MedCon - Testimonials
"There were "gems" of current thinking that came up with much greater frequency than at other conferences."
"Robust presentation content. Great networking opportunity."
"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."
A Look Inside MedCon