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Whitepapers



Our whitepapers allow you to dig deeper into topics and understand the science behind our services, as well as ways we can help solve your business challenges.



February 18, 2019

Use of Accelerated Conditions in Extractables and/or Leachables Studies

By:

The purpose of this paper is to consider the scientific basis for accelerated contact conditions (via the proper combination of...

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December 18, 2018

Regulatory Landscape for EO Residue Levels in Medical Devices

By: , Gregory Grams, Mike Padilla and Peter Strain

Ethylene oxide gas sterilization, in particular, is one of the most efficient and effective ways of deactivating bacteria and other...

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November 30, 2018

EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7

By: , Gregory Grams, Mike Padilla, Peter Strain and Erik Haghedooren

Sterilizing medical devices via ethylene oxide gas is an effective and common practice within the industry. EO gas is active...

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May 10, 2017

Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices

By: , and

Download this whitepaper to learn about the various biocompatibility and sterilization considerations surrounding 3D-printed orthopedic devices. 3D-printed orthopedic medical devices...

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March 10, 2017

Single Use & Newly Manufactured Device Cleaning Validations

By: Erin Bakes and Alexa Tatarian

Performing a cleaning validation during the initial phase of a device’s lifecycle aids manufacturers in complying with current good manufacturing...

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