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WHERE MEDICAL INNOVATIONS TAKE FLIGHT

APS researcher breaks down the challenges of ISO 10993 for E&L device testing

It’s commonplace in the CRO community: While researchers recognize the value of strict FDA rules set for biocompatibility testing, they’re continually frustrated by ISO stipulations that aren’t necessarily relevant when evaluating implantable medical devices. That means the researchers often spend unnecessary time and money on extractable and leachable (E&L) testing procedures that don’t result in […]

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