Medical Device Testing CRO

Medical Device Testing CRO

Rigorous Biocompatibility and Comprehensive Medical Device Testing

Biocompatibility testing stands as a critical juncture in the developmental trajectory of medical devices, offering profound insights into the nuanced interactions between patients and the device itself, while scrutinizing the intrinsic materials composing the device.

At AniLocus, we proudly offer an expansive suite of biocompatibility testing services, tailored to the exacting standards of medical device manufacturers. Our seasoned team brings forth substantial expertise in assessing the biocompatibility of biomaterials, aligning seamlessly with ISO 10993-1 and FDA guidance, ensuring meticulous determination of biocompatibility endpoints.

Comprehensive Biocompatibility Testing Services

Our preclinical in vivo research services are characterized by their reproducibility and comprehensiveness, positioning our team as an indispensable resource for Sponsors in the medical device development landscape. In particular, we specialize in risk assessments for medical devices and biomaterials, executing tests across various animal models. This commitment extends to providing our clientele with the highest echelon of safety and assurance throughout the biocompatibility testing process.

Detailed Biocompatibility Evaluations

Anilocus excels in conducting multiple biocompatibility evaluations as outlined in ISO 10993-1, catering to diverse facets of medical device assessments. Our suite of in vivo evaluations spans a spectrum of crucial parameters:

AniLocus delivers cutting-edge biocompatibility services for medical device manufacturers, offering a comprehensive suite of in vivo evaluations aligned with ISO 10993-1 and FDA guidance.

Contact us! Learn more about our in vivo biocompatibility testing services!

    Why AniLocus?

    Comprehensive Biocompatibility Assessments

    Leverage our team’s extensive experience in conducting thorough biocompatibility assessments, aligning seamlessly with ISO 10993-1 and FDA guidance. Our services encompass a wide array of in vivo evaluations crucial for determining the safety and compatibility of medical devices.

    Specialized Risk Assessments:

    Benefit from our in-depth risk assessments tailored to the unique requirements of medical devices and biomaterials. We employ various animal models to provide you with a nuanced understanding of potential risks, ensuring the highest level of safety assurance.

    A visually engaging photograph depicting a laboratory setting in AniLocus with scientists conducting various biocompatibility tests.

    Our Suite of In Vivo Evaluations: Precision at Every Stage

    • Cytotoxicity: We evaluate the impact of medical device materials on cell viability to ensure cellular compatibility.
    • Sensitization: We assess potential allergic reactions to materials, ensuring the safety of the device for all users.
    • Irritation or Intracutaneous Reactivity: We will examine the device’s impact on skin tissue, crucial for dermatological safety.
    • Acute Systemic Toxicity: We can dtermine the immediate systemic effects of the device, providing valuable insights for risk mitigation.
    • Material-Mediated Pyrogenicity: We assess the potential for pyrogenic reactions associated with biomaterials used in medical devices.
    • Subacute and Subchronic Toxicity: We can uncover the effects of prolonged exposure, ensuring the long-term safety and reliability of medical devices.
    • Genotoxicity: We will evaluate the impact on genetic material, essential for understanding potential long-term risks.
    • Implantation: We will assess the compatibility of materials upon implantation, providing critical data for implantable medical devices.
    • Hemocompatibility: We can examine the interaction between blood and device materials, crucial for devices with blood contact.
    • Chronic Toxicity: With our preclinical medical device testing services, we investigate the long-term effects of device exposure to ensure sustained safety.
    • Carcinogenicity: We wull assess the potential carcinogenic effects, a crucial aspect of long-term safety evaluations.
    • Reproductive/Developmental Toxicity: We will  evaluate potential impacts on reproductive health and fetal development.
    • Degradation: We can study the material’s degradation over time, vital for understanding the device’s longevity.

    Additional Information

    1. Basics of Biocompatibility: Information Needed for Assessment by the FDA. Biocompatibility Assessment Resource Center. Premarket Approval (PMA). Published 2021 March 18.
    2. Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” – Guidance for Industry and Food and Drug Administration Staff.