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
Abbott Diabetes Care
Abbott Medical Optics
American Medical Systems
Aniara Diagnostica, LLC
Ansell Medical LLC
Atlas Design + Technology
Austen BioInnovation Institute in Akron
Avery Dennison Medical
Bionix Development Corp.
Boston Scientific Corporation
C. R. Bard Inc.
Carolinas Medical Center
Cincinnati Children’s Hospital Medical Center
Cincinnati Sub-Zero Products Inc.
Cincinnati USA Partnership
Cleveland HeartLab, Inc.
Clinical Research Consultants, Inc.
Corning Life Sciences
Cynthia J. Kisiel-Smith, Inc.
Davis Medical LLC
Devicor Medical Products, Inc.
DiaPharma Group, Inc.
DuVal & Associates, P.A.
E-BEAM Services, Inc.
Eli Lilly and Company
Emergo Group, Inc.
Engineering Systems Inc.
ESI Hospital,Government of Andhra Pradesh, India
Ethicon Endo-Surgery, Inc.
Ferrosan Medical Devices A/S
Flynn Consulting Services
Food & Drug Administration
Galil Medical Inc.
GE Intelligent Platforms
Global Surgery Group, Johnson&Johnson
Gold Thread LLC
Greenleaf Health LLC
Hitachi Medical Systems America, Inc.
IHL Consulting Group
IMARC Research, Inc.
International Medicine Institute, University of Miami
Johnson & Johnson
Journal of Special Operations Medicine
Ken Block Consulting
King & Spalding LLP
Korea Health Industry Development Institute USA
Krafft Consulting International LLC
Life Science Innovation, LLC
Longwell and Associates
Material Needs Consulting
MD&D Global Services LLC
MEAS US LLC
Medical Device Control Office, Department of Health, Hong Kong SAR
Merck Consumer Care
Meridian Bioscience Inc
Moog Medical Devices Grup
National Biological Corporation
Nonin Medical, Inc.
Nordion (Canada) Inc.
Novatek Communications, Inc.
OraSure Technologies Inc
Ortho Clinical Diagnostics
Pharmacontrol Electronic GmbH
Procter and Gamble
Quality System Architects
Quality System Strategies LLC
Regulatory & Quality Solutions, LLC
Restore Medical Solutions Inc
ReVision Optics, Inc.
SFA Consulting, LLC
Siemens Medical Solutions USA, Inc.
St. Jude Medical
Strategic Regulatory Partners, LLC
Taiwan Center for Drug Evaluation
Taylor Strategy Partners
The Eriah Group, LLC
The Gray Sheet
The Ohio State University
Thermo Fisher Scientific Inc.
ThinkTalkLAF and Wa-CS
Transonic Systems Inc.
U.S. Department of Commerce – USCS
University of Cincinnati
US House of Representatives
Vancive Medical Technologies, an Avery Dennison business
Varian Medical Systems
Vascular Solutions, Inc.
Wake Forest/Preclinical Surgical Services
Wright Medical Technology
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