Comprehensive Biocompatibility Testing for Medical Devices
- Cytotoxicity study (in-vitro)
- Sensitization study (in-vivo & in-vitro)
- Irritation / intracutaneous reactivity (in-vitro & in-vivo)
- Systemic toxicity studies (acute, sub-acute, sub-chronic, chronic)
- Genotoxicity studies (in-vitro & in-vivo)
- Implantation studies
- Hemocompatibility studies
- Pyrogen testing
- Degradation and toxicokinetic studies
- Carcinogenicity testing
- Reproductive and developmental toxicity studies
What is biocompatibility testing for medical devices?
It evaluates the interaction between medical devices and biological systems to ensure safety and regulatory compliance.
Do you perform both in-vitro and in-vivo studies?
Yes, we conduct a wide range of in-vitro and in-vivo studies including cytotoxicity, sensitization, and genotoxicity.
What types of toxicity studies do you offer?
We provide systemic toxicity, carcinogenicity, and reproductive/developmental toxicity studies.
Do you support regulatory submissions?
Yes, our studies are aligned with global regulatory expectations to support approvals and compliance.
Can you test implantable devices?
Yes, we conduct implantation and hemocompatibility studies for medical device safety evaluation.
Tested for Safety. Built for Confidence.
Biocompatibility testing is critical to ensure that medical devices are safe for human use and comply with global regulatory standards. At Accuprec, we provide a comprehensive range of biocompatibility studies designed to evaluate biological responses, toxicity, and overall safety of medical devices.
Our capabilities cover in-vitro and in-vivo studies including cytotoxicity, sensitization, irritation, systemic toxicity, and genotoxicity assessments. With a strong focus on regulatory compliance and scientific accuracy, we support manufacturers in meeting international standards and ensuring patient safety.
From early-stage evaluation to regulatory submission, our biocompatibility services are designed to deliver reliable, reproducible, and audit-ready results.
Our Approach to Accurate & Compliant Testing
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.
