Skip to navigation, content

Management Roundtable| FDAnews

Why People are Talking About the Medical Device Quality Congress…

“As a repeat attendee, I highly recommend this conference. The workshops, interactive sessions and insights from reputable speakers are very useful and applicable information to take back and share with my company and colleagues.”
Heather Jalisi, Quality Assurance Manager, DexCom Inc.

“I would recommend the seminar in view of strengths of topics discussed and speakers who are well respected in industry.”
Remy Estera, Team Leader, Quality Assurance in Manufacturing, Resmed Ltd. Australia

“It was extremely refreshing to attend a conference with the focus on Medical Devices. Too often with conferences the focus is on drugs. This conference was very well done!”
Joseph Sondej, Associate Manager Quality Control, Celgene Cellular Therapeutics

“One of the most beneficial Congress’ I have ever attended.”
Alejandro Lamas, Quality Assurance Manager, Medtronic Mexico

“Compilation of insightful presentations, covering issues faced by every device manufacturer, presented by industry leaders.”
Chris Lake, Manager Quality Assurance and Regulatory Affairs, Epimed International


Valuable guidance for building effective quality systems, including:
  • What to expect from FDA and worldwide regulatory bodies with regard to managing patient risk

  • Common pitfalls inherent with many risk management programs

  • Implement a complete life cycle approach to ISO 14971 and ISO 13485 and gain internal value

  • Understand FDA enforcement actions including warning letters and certificates to foreign governments

  • Comprehend what happens when the FDA sues: 1) the “sign or sue” letter; 2) settlement options; 3) consent decree/disgorgement

  • Grasp the Federal Rules of Civil Procedures in litigation

  • Medical Device Reporting Requirements: understand what is and isn’t reportable and why

  • Hear examples of effective medical device reporting activities

  • How to avoid pitfalls in decision making criteria for what to report

  • Methods to achieve compliance with the design control requirements of the QSR

  • How to document design changes

  • Understand design inputs and outputs – what to include and not to include

  • Realize and communication how QSR affects corporate strategy

Who Should Attend:

The Second Annual Medical Device Quality Congress is ideal for Vice Presidents and Directors of:

  • Quality

  • Regulatory Affairs

  • Product Development

  • Compliance

  • Validation

  • Corporate Counsel

Participating Companies at past
Medical Device Quality Congresses:
  • Davol Inc.

  • Genzyme Corporation

  • Integra LifeSciences Corporation

  • Medrad, Inc.

  • Respironics

  • American Red Cross

  • McKenna Long & Aldridge

  • Buchanan Ingersoll


  • LifeNet

  • Andersen Sterilizers

  • Ipas

  • FUJU Photo Film

  • Pedicraft

  • GMP Companies

  • Medex

  • Reliance Medical Products

  • Cook Urological

  • Boston Scientific

  • MicroBiologics

  • Mallinckrodt Tyco Healthcare

  • CMS Inc.

  • Whiteside Biomechanics Inc.

  • Perkins Electronics

  • Alliance Medical Corporation

  • Karl Storz Endoscopy

  • America

  • Amphastar Pharmaceuticals

  • Safety Syringes Inc.

  • ResMed Corp

  • Gen-Probe Inc.

  • DexCom

  • Plus Orthopedics

  • Medimexico

  • Guidant Corporation

  • Endologix

  • B Braun Medical

  • Quintiles

  • Synergy Biomedical

  • Abbott Laboratories

  • Micrus Corporation

  • Biorad Laboratories

  • Insound Medical

  • Bayer Diagnostics

  • Dow Pharmaceutical Sciences

  • Welch Allyn

  • ResMed Australia

  • Orion Canada

  • GlaxoSmithKline Canada

  • Xillix Technologies Corp Canada

  • Inion Oy Finland

  • Aventis Germany

  • AB Biodisk Sweden

  • Unipath Ltd UK

  • MacroPore

  • DexCom


  • Medtronic

  • Baxter

  • Sybron

  • LabNow


  • Gambro BCT

  • Nelson Laboratories

  • Diagnostic Products Corporation

  • Blue Sky Medical

  • Breg Inc.

  • Smiths Medical

  • Medrad

  • Medical Graphics

  • Nanosphere

  • Beckton Dickinson

  • Stryker

  • Philips Medical Systems

  • Biogen Idec

  • Johnson & Johnson

  • Medrad

  • Neuronetics

  • Celgene Cellular Therapeutics

  • ApoPharma

  • Sanofi Aventis

  • Ansell Kedah Sdn Bhd

  • Steris Corporation

  • Reliance Medical Products

  • Terumo Heart

  • Kyphon

  • Affymetrix

  • Sciemetric Instruments

  • TM Bioscience

Conference Info:

Register Now
Pre-Conference Workshops
Featured Presentations
About MRT & FDAnews
Become a Sponsor
Fees & Logistics

Download Brochure

pdficon.gif (912 bytes) MD06-brochure.pdf

For conference news
and updates, join our mailing list:

Last Name

Presented by:


Sponsored by:


© Copyright 2004 by Management Roundtable, Inc. & FDAnews. All rights reserved.