Biocompatibility testing is the cornerstone of patient safety and a mandatory requirement under ISO 10993 series and USFDA (21 CFR Part 58, 812) guidelines.

Accuprec offers an extensive suite of in-vitro and in-vivo biocompatibility studies to evaluate the interaction between medical device materials and biological systems.

Our Capabilities Include:

• In-Vitro Cytotoxicity Testing (ISO 10993-5): Qualitative and quantitative assessment using cell culture assays (MTT, MEM Elution, Direct Contact).
• Sensitization & Irritation Studies (ISO 10993-10 & -23): Evaluation of dermal, ocular and mucosal irritation potential.
• Systemic Toxicity Studies (ISO 10993-11): Acute, sub-acute, sub-chronic and chronic systemic exposure testing.
• Implantation Studies (ISO 10993-6): Evaluation of local tissue response post-implantation (subcutaneous, intramuscular, intraocular).
• Hemocompatibility Testing (ISO 10993-4): Includes hemolysis, coagulation and complement activation studies.
• Genotoxicity and Carcinogenicity (ISO 10993-3): Ames test, chromosomal aberration and in-vivo micronucleus assay.
• Degradation & Toxicokinetic Studies (ISO 10993-9 to -16): Analysis of degradation pathways and kinetics of breakdown products.

Why Choose Accuprec

• End-to-end study design, execution and data interpretation by expert toxicologists.
• GLP-compliant documentation accepted by global regulatory authorities (EU MDR, USFDA, CDSCO).
• Support for Biological Evaluation Report (BER) preparation.

Outcome: Reliable, regulator-accepted biocompatibility data ensuring biological safety and faster product approvals.