Exhaustive Extractions

At iuvo, we work hard to stay on the cutting edge of new developments in testing and regulatory changes affecting the medical device and pharmaceutical industries. We will share these updates regularly here in our blog - Exhaustive Extractions.

iuvo Workshop at the University of Rochester to Introduce ISO-10993 to Engineering Students

On Friday, March 8, 2019, Dr. Mary Richardson and Dr. Kathleen Krenzer from iuvo's toxicology department lectured and conducted a workshop on ISO-10993 Biocompatibility testing at the University of Rochester.


 

The workshop was conducted for Biomedical engineering students taking a graduate level course on medical devices.  The primary goal was to help the students understand the scope and requirements of ISO-10993 testing, the documentation involved, and how to build a strategy so they could apply these concepts to their medical device prototype projects.

With Greg T. Gdowski, PhD, Executive Director, Associate Professor, Department of Biomedical Engineering

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iuvo Staff Co-authors Paper on Pig-a Gene Mutation by Flow Cytometry

March 4, 2019 – Several members of the iuvo BioScience toxicology team co-authored a paper entitled Suitability of Long-Term Frozen Rat Blood Samples for the Interrogation of Pig-a Gene Mutation by Flow Cytometry.

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ISO Publishes New Technical Standard: ISO/TS 21726:2019 Biological Evaluation of Medical Devices

The International Standards Organisation (ISO) recently published a new technical standard, ISO/TS 21726:2019 Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents. 

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FDA Lists ISO 10993-1:2018 as a Recognized Consensus Standard

On January 14, 2019, the FDA announced recognition (partial) of ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.

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iuvo Co-Authors Paper on Socially Housing New Zealand White Rabbits

October 21, 2017 - Members of the iuvo toxicology team co-authored a paper in the October 2017 issue of Comparative Medicine, the international journal of the American Association for Laboratory Animal Science.

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