Publications


Current Trends at FDA: Implications for Data Requirements
01/2013
Ann Quinlan-Smith and Rita Kraus
DeviceMed Germany - January Excerpt (German)
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BMC Musculoskeletal Disorders
12/22/2009
Nicholas McArthur , Lydia Heimann , Elvira Dingeldein , Héloïse Cavey , Xavier Palazzi , Gaëlle Clermont, Franz-Xaver Huber and Jean-Pierre Boutrand
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Biological Safety: More Than Just Test Data
1/1/2009
David Parente
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A Practical Guide to ISO 10993-12: Sample Preparation and Reference Materials
12/1/2008
Timothy Jansen and Richard F. Wallin
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A Practical Guide to ISO 10993-4: Hemocompatibility
11/1/2008
J. Matthew Buchanan, Paul J. Upman, and Richard F. Wallin
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A Practical Guide to ISO 10993-3: Genotoxicity
10/1/2008
Gina M. Johnson, Paul J. Upman, and Richard F. Wallin
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Assessing the Biological Safety of Polymers
9/1/2008
David Albert and Amy Hoffmann
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A Practical Guide to ISO 10993-11: Designing Subchronic and Chronic Systemic Toxicity Tests
9/1/2008
Louis E. Sendelbach and Richard F. Wallin
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A Practical Guide to ISO 10993-6: Implant Effects
8/1/2008
Richard F. Wallin and Paul J. Upman
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A Practical Guide to ISO 10993-11: Systemic Effects
7/1/2008
Richard F. Wallin and Paul J. Upman
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A Practical Guide to ISO 10993-10: Irritation
6/1/2008
Richard F. Wallin and Paul J. Upman
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Using Chemical Characterization to Show Equivalency
5/1/2008
David Albert PhD and Amy Hoffmann
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A Practical Guide to ISO 10993-10: Sensitization
5/1/2008
Richard F. Wallin and Paul J. Upman
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A Practical Guide to ISO 10993-5: Cytotoxicity
4/1/2008
Richard F. Wallin and Edward F. Arscott
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A Practical Guide to ISO 10993-14: Materials Characterization
2/1/2008
David E. Albert and Richard F. Wallin
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A Practical Guide to ISO 10993-3: Carcinogenicity
1/1/2008
Paul J. Upman and Richard F. Wallin
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A Practical Guide to ISO 10993: Part 1 - Introduction to the Standards
1/1/2008
Richard F. Wallin and Paul J. Upman
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Evaluating Pharmaceutical Container Closure Systems
1/1/2008
Dr. David E. Albert
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Antimicrobial Efficacy Comparison of Floor Coverings
1/1/2008
Beth Joiner
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Progress in Testing
1/1/2008
Dr. Paul J. Upman
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The Growing Importance of Materials Characterization in Biocompatibility Testing
1/1/2008
Dr. David Albert
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Biological Indicator Characterization
3/29/2007
Joel R. Gorski, PhD
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Making Sure It's Sterile
7/1/2006
John Broad and Laurie Nawrocki
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The Challenge to Global Acceptance of Part 3 of ISO 10993
6/1/2006
Dr. Joseph Carraway and Dr. Molly Ghosh
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ISO 10993-6: Tests for Local Effects After Implantation
4/1/2006
Paul J. Upman, Ph.D.
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Avoiding Loss of Medical Information During Clinical Investigations
5/1/2005
Raphael Gruber
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The Expanding Role of Contract Research Organizations
4/1/2005
Dr. Paul Upman and Terry Langenderfer
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When To Conduct A Clinical Trial
10/1/2004
J.P. Boutrand
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The Important Role Of Material And Chemical Characterisation In Device Evaluation
8/1/2004
David E. Albert
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Outsourcing Testing Services
7/20/2004
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The Growing Importance of Materials Characterization in Biocompatibility Testing
3/1/2002
Dr. David E. Albert
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Progress in Testing
9/1/2001
Paul J. Upman, NAMSA
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BIOMATECH NAMSA Testing Laboratory Prevention of bacterial adhesion to medical polymers
9/1/2001
Docteur Sophie BOBIN-DUBREUX
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Current and Future Issues in Sensitisation Testing
9/1/2001
R. Eloy, F.Charton-Picard, C. Delubac and S.Kergozien
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Validating Reusable Medical Devices: An Overview
1/1/1996
Susanne Anderson, Ed Arscott, John Broad, and Dave Parente
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Satisfying Medical Device Biocompatibility Requirements: What's a Supplier to Do?
1/1/1996
Paul J. Upman, NAMSA, Inc. & Robert Charton, Norton Performance Plastics
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