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.

Join us for our Webinar on Biocompatibility and the EU MDR

iuvo will be teaming up with R&Q for a webinar on Biocompatibility: EU MDR and the Changing Regulatory Landscape.  The webinar is March 26, 2019, from 1-2pm ET. The slides, webinar recording, and Q&A will be made available to registrants after the webinar.

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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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FDA Delays Implementation of Changes to "Intended Use"

On January 16, 2018, the FDA announced that the Agency will be delaying implementation of parts of its "intended use" rule due to concerns raised by the industry.

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Recent FDA Announcements - Accessories and Least Burdensome Provisions

There's frequently a flurry of FDA announcement near the end of the year, and this year was no exception.  We wanted to highlight a couple of the more pertinent ones that may be of interest to our customers.  The summaries below link to some of the more interesting guidance documents recently released.

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