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December 19, 2018

How To Address Device And Regulatory Change From A Biocompatibility Perspective

Many devices are a modified version of the “clean slate” device that was placed on the market decades ago and devices frequently change hands from one company to another and are submitted to new markets. Currently, biocompatibility is one of...

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December 10, 2018

New Regulatory Changes that Impact Medical Devices: Using Chemistry to Assess Safety

This presentation will provide a snapshot of a shifting regulatory landscape that is evolving with the new release of ISO 10993-1, the MDRs, and draft ISO 10993-18. An overview of the strategic options available for the evaluation of medical device...

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November 28, 2018

The Journey of Revealing Unknowns and Impurities by Material

This presentation was delivered at the CPhI tradeshow in Madrid, Spain on June 14, 2018. Passports, ID cards, fingerprints, metal detectors, iris recognition, camera’s… we are trying to reveal the journey of “unknowns” to ensure safety and to avoid disaster....

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June 12, 2018

MD&M East Tech Theater: The Future of Biocompatibility Industry Trends and Hurdles

The regulatory environment for the biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have traditionally been addressed with biocompatibility testing on animals; however, alternate options are now available to reduce animal testing by using...

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April 19, 2018

The Future of Biocompatibility: Industry Trends and Hurdles

The regulatory environment for the biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have traditionally been addressed with biocompatibility testing on animals; however, alternate options are now available to reduce animal testing by using...

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