Laboratory Test Request

ISO 10993 Testing on Class IIb Medical Devices

Project Description

Contract Medical Device Laboratory needed for ISO 10993 testing on Class IIb medical devices, concentrates for bicarbonate hemodialysis:
- Evaluation of the associated biological endpoints and relevant testing according to ISO 10993,
- Biological Evaluation Plan (BEP)
- Physical and/or chemical information
- Toxicological Risk Assessment taking into consideration the worst-case intended patient population
- Degradation
- Absorption, Distribution, Metabolism, and Excretion (ADME) endpoint
- Biological Evaluation Report (BER)
We are a manufacturer of Class IIb medical devices, concentrates for bicarbonate hemodialysis that are MDD-certified in 2010 (first certification). We are in the process of CE certification according to Medical Devices Regulations (MDR). Please send an offer with a timeline for finishing all related activities.

Project Information


Industry:Medical Devices

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