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
  • 150+ Companies
  • 26 States
  • 8 Countries
  • 19 FDA Representatives

Attending Organizations

  • Abbott
  • Abruzzo Regulatory Affairs Consulting, LLC
  • Advanced Sterilization Products
  • Alcon
  • Allergan
  • Americas Blood Centers
  • Amylin
  • Anson Group
  • AtriCure, Inc.
  • Battelle
  • Baxter Healthcare
  • Becton Dickinson
  • Bio-Rad Laboratories
  • BioEnterprise
  • Biomet
  • BioOhio
  • Biotechnology Consulting Solutions, Ltd.
  • BNA
  • Boston Scinetific
  • BSI
  • Cardioinsight Technologies
  • Carestream Health, Inc.
  • CCHMC
  • 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
  • Covidien
  • Device & Implant Innovations LLC
  • Devicor Medical Inc.
  • DG Medical
  • DiaPharma Group, Inc.
  • DuVal & Associates, P.A.
  • E-BEAM Services, Inc.
  • Eagle Creek Engineering
  • Eli Lilly
  • Engisystems
  • Ethicon Endo-Surgery
  • EXCMR, Inc.
  • Expert Medical Device Consulting, Inc.
  • Faegre Baker Daniels
  • FDA
  • FDAnews
  • Flanders Investment and Trade
  • Flynn Consulting Services
  • Gold Thread LLC
  • Google
  • Harvard University
  • Hill-Rom, Inc.
  • Hitachi Medical Systems America
  • Hospira
  • IHL Consulting Group
  • IMARC Research Inc.
  • Integware
  • Invacare Corp.
  • Invibio Limited
  • Ischemia Care
  • ITC
  • Johnson & Johnson
  • King & Spalding LLP
  • Krafft Consulting Intl LLC
  • Life Science Innovation, LLC
  • Mallinckrodt
  • MAQUET
  • McGuire VA Medical Center
  • McNeil Consumer Healthcare
  • Medtronic
  • Meridian Bioscience Inc
  • MIDMARK Corporation
  • MiraVista Diagnostics, LLC
  • Mound Laser & Photonics Center
  • Neil Burris & Associates
  • Nobel Biocare
  • Orthopedic Generations LLC
  • P&G
  • PCG, LLC
  • Pew Charitable Trusts
  • Pfizer
  • Philips Healthcare
  • Pioneer Surgical
  • Plus Pillow, Inc.
  • Procter & Gamble
  • Quality Alliance
  • Quality System Architects
  • QualityMetric Incorporated
  • REGSolutions, LLC
  • Regulatory & Quality Solutions
  • Regulatory Compliance Associates
  • RHoffman, Inc
  • Roche
  • Roche Diagnostics
  • Saudi Food & Drug Authoritey
  • ScottCare Corporation
  • Sensors for Medicine and Science
  • Small Business Administration
  • SNS Nano Fiber Technology, LLC
  • SpineForm LLC
  • St. Jude Medical
  • Sterigenics
  • STERIS Corporation
  • Strategic Regulatory Partners, LLC
  • Stryker
  • Sybron Dental Specialties
  • Symmetry Medical
  • The Gray Sheet
  • The Health Foundation
  • The Mastery Institute
  • The Silver Sheet / Elsevier
  • Thermo Fisher Scientific Inc.
  • TranS1
  • 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.
  • VasoStar Inc.
  • West Chester Township
  • X-spine Systems Inc.
  • Xavier University
  • Zimmer, Inc.

Thank you to our 2013 Sponsors!

 

abbott-logo_175_72
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