Biocompatibility testing and evaluation services for medical devices and biomaterials, assessing safety and regulatory compliance. Services include preclinical research, material compatibility assessment, and support for device registration across international markets.
Manufactured by
Suzhou Yipin Quality Technical Service Co., Ltd
China
EPIN is a government-backed medical device technical service platform providing testing and contract research organization (CRO) services for medical devices and biopharmaceuticals. The company operates laboratories accredited by CNAS, CMA, US FDA GLP, and ILAC ISO 17025, serving China, US, and European markets. Services include electrical safety testing, EMC compatibility, animal studies, biocompatibility, sterilization validation, package aging, chemical characterization, risk analysis, finite element analysis, software evaluation, usability engineering, and clinical evaluation.
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Jiangsu Kerbio Medical Technology Group Co., Ltd. · China
Comprehensive biocompatibility and safety testing services for medical devices and biomaterials, including in vitro cytotoxicity assays, animal toxicology studies, material characterization, and sterility validation. Testing adheres to ISO 10993 standards and supports regulatory approval pathways for implantable devices and patient-contact materials.
Jiangsu Bosaifu Medical Technology Co. , Ltd. · China
Medical device safety evaluation services for regulatory compliance and risk assessment. Provides comprehensive testing, biocompatibility analysis, and standards compliance documentation to support market approval and device certification across global markets.
SAXOCON A/S · Denmark
Comprehensive biological safety evaluation service for medical devices ensuring compliance with ISO 10993 standards. Includes toxicological risk assessment and biocompatibility testing through validated in-silico methodologies and data analysis.
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