May 6-8, 2014
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 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

Xavier MedCon in the News: CDRH Official: Compliance Approach May Need Tweaks, More Flexibility

  1. Review our 2013 conference presentations
  2. Review 2013 Session Recaps
  3. 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
  • Varian Medical Systems
  • Vascular Solutions, Inc.
  • Viable Synergy
  • Wake Forest/Preclinical Surgical Services
  • Wipro Technologies
  • Wright Medical Technology
  • Xavier University
  • X-spine Systems, Inc.
  • YSI Inco
  • Zimmer Surgical

Thank you to our 2013 Sponsors!

 

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roche_logo
BSC_wtag_541blue Engisystems_Logo-(2) cm_logo
LRQA_BusAssur_Logo_Burg EBEAM Logo Procter & Gamble QSArchitectsLOGO
GBI-Logo0  Acquireweblogo

 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

Food and Drug Administration Xavier University