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Author: Audrey P. Turley





June 25, 2018

How Clean is Clean Enough?

Here are some takeaways from ISO 19227 for orthopedic implants. ISO 19227 Implants for Surgery–Cleanliness of Orthopedic Implants–General Requirements is a long-awaited guidance document that was finalized and published early 2018. This guidance document is intended to assist orthopedic medical...

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September 8, 2016

How Chemical Characterization Can Supplement and Support Biocompatibility Testing

Download this whitepaper to examine the various ways in which chemical characterization can augment and refine the biocompatibility testing process. Using analytical chemistry and data from the compound libraries to assess the finished device can yield more specific data about...

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April 12, 2016

3D Printed Devices and Biocompatibility

The use of three-dimensional (3D) printing techniques to address challenging fabrication problems has become mainstream over the past decade. While this rich resource has extended fabrication of personalized medical devices to the limit of our imagination, the myriad materials and...

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January 20, 2016

FDA Guidance for ISO 10993-1: What to Expect

Several noteworthy changes are anticipated in a new FDA guidance document on biological evaluation and biocompatibility testing of medical devices due out sometime this year. Read Full Story

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