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Updates to ISO 10993-1 and ISO 21726

The approach expected by regulators for the evaluation of medical device biocompatibility has been rapidly changing as expectations within regulatory bodies has been shifting. This shift is fueled in part by two newly minted standards: ISO 10993-1 and ISO 21726. This presentation will provide an overview of what is new with these two documents as they apply to manufacturers seeking to get a device onto market.