After 10993-18 new revision issuance (2020) several questions have arisen on how general directions contained in the standard are implemented by the authorities.
This webinar aims to bridge the gap between ISO 10993-18 and authorities requirements for medical device extractables. By offering practical insights into topics such as methods qualification, AET definition, extraction conditions and others, the webinar equips participants with the knowledge and tools needed to ensure compliance with the authorities expectations.
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