Resources

Here you’ll find a complete collection of downloadable white papers, articles, and case studies – all designed to help you perform better, make important decisions, improve your testing processes, and get better business results. If there is a topic you’d like to see covered or if you’d like to be featured in a case study, please let us know.

Looking for in-depth information?

Our white papers and published articles allow you to dig deeper into topics and understand the science behind our service as well as ways we can help solve your business challenges. We’ve also gathered links to valuable industry resources and organizations that can help you learn about related topics and further your career in testing.

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

Cold EO Sterilization: Cool Process for Novel Products
Source: Medical Device Summit: July 2011

Radiation Sterilization Failures: What Can Go Wrong?, written by Martell Winters of Nelson Labs. Featured in BI&T Magazine, May/June 2011

How to Feel Positive about a Biocompatibility Test Failure, written by Thor Rollins of Nelson Labs. Source: Medical Device Summit

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:
Source: Medical Product Outsourcing: June 2010.

Global Medical Device Outsourcing Market to Reach US$42.6 billion by 2015

Source: Qmed

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."

Source: BioPharm International.com, April 2009

"To Assess or to Determine? Unraveling the D-Value"
Source: MDDIonline.com, March 2010

The Big Three
Source: MedicalDeviceNow.com

"How to Feel Positive about a Biocompatibility Test Failure"

Source: MedicalDeviceSummit

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