MEDICAL DEVICES

MEDICAL DEVICES

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PRECLINICAL TESTING SERVICES

Biocompatibility Testing

Comprehensive biological safety evaluation services compliant with
ISO 10993 and OECD guidelines for medical devices and biomaterials.

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IN-VIVO STUDIES

Skin Sensitization (ISO 10993-10)
Systemic Toxicity (ISO 10993-11)
Irritation (ISO 10993-23)
Haemocompatibility (ISO 10993-4)
Pyrogenicity (ISO 10993-11)
Implantation (ISO 10993-6)
In-Vivo Mammalian Erythrocyte Micronucleus Test (OECD 474)
In-Vivo Mammalian Bone Marrow Chromosome Aberration Test (OECD 475)

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IN-VITRO STUDIES

Cytotoxicity Evaluation (ISO 10993-5)
Genotoxicity (ISO 10993-3 and ISO 10993-33)
Bacterial Reverse Mutation Test (OECD 471)
Mammalian Cell Gene Mutation Test (OECD 476)
Mammalian Chromosome Aberration Test (OECD 473)
Mammalian Cell Micronucleus Test (OECD 487)

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