In - Vivo Studies
Comprehensive In-Vivo Biocompatibility And Safety Testing For Medical Devices As Per ISO 10993
OUR PRE CLINICAL SERVICES
Medical Device In - Vivo Studies
We provide comprehensive in-vivo biocompatibility and safety evaluation for medical devices in accordance with ISO 10993 guidelines, supporting product development, regulatory compliance and clinical safety.
In - Vivo Studies Services Scope
In - Vivo Studies for Medical Devices (ISO 10993):
Intracutaneous Reactivity / Skin Irritation- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Skin Sensitization (GPMT/Buehler)
- Mucosal Irritation Test (Oral Mucosa, Penile, Vaginal, Rectal and Ocular Irritation)
- Implantation study (Local Tissue Effects after Implantation)
- Biocompatibility Studies for medical device as per ISO 10993
- Sub-Acute Toxicity
- Sub-Chronic Toxicity
- Chronic Toxicity
- Preparation of Biological Evaluation Plan and Biological Evaluation Report
- Toxicological Risk Assessment
ADVANCE MEDICAL DEVICE TESTING
We Perform Below Mentioned Studies in RRC:
Ribosome Research Centre delivers comprehensive biocompatibility evaluation, toxicological risk assessment, and specialized testing in compliance with OECD GLP, ISO, and global regulatory standards.
Our Process
Our Approach To Accurate &
Compliant Testing
Build your career in a research environment that values scientific curiosity, quality and teamwork. At Ribosome Research Centre, people
contribute to work that supports the understanding of products and the evidence behind development decisions.
Requirement Understanding
We begin by understanding your product, testing requirements, and regulatory objectives to define a clear analytical strategy.
Method Development & Planning
Our team develops and optimizes analytical methods, ensuring alignment with ICH, USP, and global regulatory standards.
Testing & Analysis
Samples are tested using advanced instrumentation such as LC-MS/MS, ICP-MS, and other validated techniques for accurate results.
Reporting & Compliance Support
We deliver detailed, audit-ready reports and provide support for regulatory submissions and compliance requirements.
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