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:
2013 Demographics
357 participants
163 Companies
26 States
8 Countries
19 FDA Representatives
Attending Organizations
Abbott Diabetes Care
Abbott Laboratories
Abbott Medical Optics
Abbvie
Accenture
Alcon
American Medical Systems
Amgen
AMRESCO
Aniara Diagnostica, LLC
Ansell Medical LLC
ARAC, LLC
Atlas Design + Technology
AtriCure, Inc.
Austen BioInnovation Institute in Akron
Avery Dennison Medical
Battelle
Baxter Healthcare
Bayer Healthcare
BD
Biomet
Bionix Development Corp.
Bloomberg BNA
Boston Scientific Corporation
C. R. Bard Inc.
CardioMEMS
Carestream
Carolinas Medical Center
Cincinnati Children’s Hospital Medical Center
Cincinnati Sub-Zero Products Inc.
Cincinnati USA Partnership
Cincom Systems
CincyTech
Cleveland HeartLab, Inc.
Clinical Research Consultants, Inc.
Coltene Whaledent
Compliancce-Alliance
ConMed Corporation
Cook Group
Cook Medical
Corning Life Sciences
Covidien
Cynthia J. Kisiel-Smith, Inc.
Davis Medical LLC
Devicor Medical Products, Inc.
DiaPharma Group, Inc.
DuVal & Associates, P.A.
E-BEAM Services, Inc.
EdgeOne Medical
EDWARDS LIFESCIENCES
Eli Lilly and Company
Elsevier
Emergo Group, Inc.
Engineering Systems Inc.
EngiSystems
ESI Hospital,Government of Andhra Pradesh, India
Ethicon Endo-Surgery, Inc.
Evidence Partners
EXCMR, Inc.
FDAnews
Ferrosan Medical Devices A/S
FlowFX
Flynn Consulting Services
Food & Drug Administration
Galil Medical Inc.
GE Intelligent Platforms
Global Surgery Group, Johnson&Johnson
Gold Thread LLC
Greenleaf Health LLC
Heyer America
Hitachi Medical Systems America, Inc.
IHL Consulting Group
IMARC Research, Inc.
Integware
International Medicine Institute, University of Miami
Ischemia Care
Jalex Medical
Johnson & Johnson
Journal of Special Operations Medicine
K2M Inc
Karen O’Leary
Ken Block Consulting
King & Spalding LLP
Korea Health Industry Development Institute USA
Krafft Consulting International LLC
Life Science Innovation, LLC
Longwell and Associates
LRQA
Maetrics LLC
Mallinckrodt
Material Needs Consulting
MD&D Global Services LLC
MEAS US LLC
Medical Device Control Office, Department of Health, Hong Kong SAR
Medtronic, Inc.
Merck Consumer Care
Meridian Bioscience Inc
MiraVista Diagnostics
MiraVista Diagnostics
Moog Medical Devices Grup
Nanofiber Solutions
Nanovis
National Biological Corporation
Nobel Biocare
Nonin Medical, Inc.
Nordion
Nordion (Canada) Inc.
Novatek Communications, Inc.
NSF Pharmalytica
OraSure Technologies Inc
Ortho Clinical Diagnostics
PCG, LLC
Pfizer, Inc.
Pharmacontrol Electronic GmbH
Philips Healthcare
Pioneer Surgical
Procter and Gamble
Quality System Architects
Quality System Strategies LLC
QUARA Innovations
Regulatory & Quality Solutions, LLC
Restore Medical Solutions Inc
ReVision Optics, Inc.
Roche
ScottCare Corp
Senseonics, Incorporated
SFA Consulting, LLC
Siemens Medical Solutions USA, Inc.
Sonivate Medical
SpineForm LLC
St. Jude Medical
Sterigenics
STERIS Corporation
Strategic Regulatory Partners, LLC
Stryker Instruments
Sway Medical
Symmetry Medical
Taiwan Center for Drug Evaluation
Taylor Strategy Partners
TBM
The Eriah Group, LLC
The Gray Sheet
The Ohio State University
Thera-Business
Thermo Fisher Scientific Inc.
ThinkTalkLAF and Wa-CS
Tornier
TranS1
Transonic Systems Inc.
U.S. Department of Commerce – USCS
University of Cincinnati
US House of Representatives
Vancive Medical Technologies, an Avery Dennison business
"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."
