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FDA Recognizes ISO 10993:17

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FDA Approved

The FDA has just recognized the recently updated ISO 10993 Part 17 standard covering the toxicological risk assessment of medical device constituents. Apart from a few exceptions, the FDA recognized the standard for its relevance and scientific and technical merit.

ISO 10993-17:2023 introduces some new concepts for toxicological risk assessments, such as toxicological screening limits (TSLs) and maximum estimated exposure dose (EEDmax), which will improve accuracy and reliability. These significant changes impact medical device manufacturers when preparing to introduce or update products.

As our CTO, Carsten Baun Senholt, is a member of the international technical committee TC 194, which designed the new standard, we are well positioned to offer fully compliant, certified QMS and toxicological risk assessments.

Read more about how we can help you with ISO 10993-17 compliance:

Biological Evaluation Report
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