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- Common Causes of Failures and How to Correct Them, published in PMPN Magazine, January/February 2014. Written by Wendy Mach
- Using Statistics as a Risk Analysis Tool for Selecting An Alternate SAL, published in Industrial Sterilization.
- FDA Trends for Reusable Medical Device Reprocessing Validations, published in MDDI Magazine, March 2012. Written by Alpa Patel & Mike Neilson.
- In Reprocessing Devices, Human Factors Matters, published in MDDI Magazine, October 2012. Written by Alpa Patel.
- Nelson Labs Selected for DuPont Tyvek Transition Project Testing, published in PMPN Magazine, May 2012 issue.
Design Considerations For Medical Device Manufacturers, published in Horizons May 2012 issue.
This article was originally published in the spring 2012 issue of Horizons , a series of special-topic magazines from the Association for the Advancement of Medical Instrumentation, www.aami.org . Posted with permission from AAMI. Any other distribution of AAMI-copyrighted material requires written permission from AAMI.
- Medical Device Packaging Validation Testing 101. Published in Medical Design Briefs, September 2011.
- New Pouch Designs Put to Test: Dental and Medical Pouch Maker Relies on Third-Party Testing for 501(K) Process. August 2011, Featured in Healthcare Packaging
- Radiation Sterilization Failures: What Can Go Wrong ?, written by Martell Winters of Nelson Labs. Featured in BI&T Magazine, May/June 2011
- The Big Three: Tests Manufacturers Need to Know , written by Thor Rollins of Nelson Labs. Featured in Medical Design Technology July/August 2010 issue.
- Analyze This: Medical Device Cleanliness written by Tina May and Brent Shelley of Nelson Labs. Featured in MDDI July 2010.
- Medical Device Testing : Start with a Strategy & Plan. Written by Dr. Jerry Nelson and Amy Karren of Nelson Labs. Featured in Medical Design Briefs, July 2010.
Last But Not Least: Packaging and sterilization are critical for compliance and speed to market:
- Medical Product Outsourcing : June 2010.
- Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump- Premarket Notification [510(k)] Submissions
- How to tell if my device is really clean written by Nelson Laboratories and appeared in Medical Design Technology June 2008.
- Submitting Radiation Samples? Document assisting clients sending samples to Nelson Labs that have been exposed to radiation
- ISO 17025 or 9001 for supplier qualification ?
- Analyzing Particulate Matter on Medical Devices written by Nelson Laboratories and appeared in MD&DI May 2009
- Keys to Successful Laboratory Testing written by QA Manager Sherri Robbins of Nelson Laboratories. Published in the PMF Newsletter.
- Comparative Analysis of EO Residuals Standards 1995-2008
Benefits of Effective Communication with a Contract Analytical Laboratory : How to handle out-of-specification results in contract analytical work.
- BioPharm International.com , April 2009
To Assess or to Determine? Unraveling the D-Value"
- MDDIonline.com , March 2010
The Big Three
A Review of Reported Recalls Involving Microbiological Control 2004-2011 with Emphasis on FDA Considerations of "Objectionable Organisms"
- American Pharmaceutical Review , January 2012
- FDA provides guidance to Pharmaceutical and Device manufacturers concerning Heparin adulteration . February 2012.