SAVE THE DATE
Mark your calendar for the 13th Annual Medical Device Quality Congress taking place March 15-17, 2016 in Bethesda, MD. Also join us for the training-session focusing on managing & auditing medical device supplier quality.
Testimonials From Past Attendees:
“This event is the best conference for medical device manufacturers. Always state-of-the-art topics and insightful talks from FDA officials. Relevant and comprehensive every year.”
– Paul A. Arrendell, Vice President Global Quality, Kinetic Concepts, Inc.
“Very thorough presentations by excellent presenters.”
– Craig Henderson, Quality and Regulation Manager, Pathfinder Therapeutics, Inc.
“Very pleased that most speakers were directly from industry, either FDA or corporations. Good to hear directly from the source.”
– Rossellen Miller, Product Development Quality Engineer, Terumo Cardiovascular, Inc.
2015 Faculty Included Experts From FDA and Industry:
FDA and Ex-FDA
- Ron Brown, Chief, Recall Branch, Division of Risk Management Operations, Office of Compliance, CDRH, FDA
- Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding; former Deputy Associate Commissioner for Regulatory Affairs and Chief Operating Officer of the ORA, FDA
- Elaine Messa, President, NSF Health Sciences, Medical Device Consulting; former director of the Los Angeles District, FDA
- William MacFarland, Director, Division of Manufacturing and Quality, OC, CDRH, FDA
- Erin Keith, Director, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, ODE, CDRH, FDA
- Suzanne Schwartz, MD, MBA, Director, Emergency Preparedness/Operations and Medical Countermeasures, OCD, CDRH, FDA
- Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH, FDA
- Dan O’Leary, President, Ombu Enterprises
- John Avellanet, Managing Director & Principal, Cerulean Associates LLC
- Patrick Caines, Director, Product Surveillance, GE Healthcare
- Larry Kopyta, Vice President, Quality Assurance & Regulatory Affairs, Omnyx, LLC
- Karl Vahey, Senior Director Global Quality and Compliance, Covidien
- Paul Brooks, Senior Vice President, BSI Healthcare Solutions
- Deb Kacera, Regulatory and Industry Strategist, Pilgrim Quality Solutions
- Julie Larsen, Principal, Director Inspection Readiness Services, BioTeknica
- Bob Marshall, Director of Business Development, Regulatory & Quality Solutions, LLC
- Steven Walfish, President, Statistical Outsourcing Services
Past Companies That Have Benefited:
Advanced Sterilization Products
Angel Medical Systems
Becker & Associates Consulting, Inc.
Berlin Heart GmbH
BSN Medical Inc.
Coastside Biotech Consultants
DSM Dyneema LLC
Fisher & Paykel Healthcare
GI View Ltd.
Heraeus Medical Components
J&J Vision Care
Johnson & Johnson
Kao USA, Inc.
Ken-Mar Mfg Corp
King & Spalding
KMC Systems, Inc.
Life Cell Corporation
Matrix Resource Solutions, LLC
Menson & Associates
Newport Medical Instruments
Oxford Performance Materials, LLC
Pathfinder Therapeutics, Inc
Phillips Consulting Group
Regulatory & Quality Solutions LLC
Safety Research & Strategies
Siemens Healthcare Diagnostics
Smith & Nephew
St. Jude Medical
Stellartech Research Corporation
Sunquest Information Analyst
Terumo Cardiovascular Systems Corp.
Terumo Medical Corporation
The Ohio State University Wexner Medical Center
Verisante Technology Inc.
Zeus Industrial Products