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MEDICAL DEVICES

A solid and comprehensive biological evaluation. From risk analysis, including physico-chemical and toxicological study monitoring through to the final biological evaluation report.

As a provider independent from CROs, CEHTRA can manage the entire risk analysis process including physico-chemical and toxicological study monitoring, as well as the formalisation of the final biological evaluation report.

According to the ISO 10 993 standard (part 1 to 20), Medical Devices have to comply to new requirements related to Biological Medical Devices Assesment.

If you are looking for support at every stage of this process, or just individual steps, including the Biological Evaluation Report by an ERT toxicologist, we can be there.
 

MEDICAL DEVICES
Marie-Charlotte BERNIER
Marie-Charlotte BERNIER
Toxicologist
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