Biocompatibility Testing Laboratories | ISO 10993 Medical Device Testing

Medical device developers face a critical responsibility: ensuring their products are safe, effective, and compliant with global standards. Biocompatibility testing plays a central role in meeting those requirements, giving manufacturers and regulators confidence that a device can safely interact with the human body. Here at Canyon Labs, we specialize in helping companies navigate this essential part of medical device development.

Biocompatibility testing evaluates how a medical device and its materials interact with biological systems. These tests are performed according to the ISO 10993 framework, which sets the global standard for assessing the biological safety of medical devices. Depending on the device type and intended use, testing may include a combination of cytotoxicity, sensitization, irritation, and systemic evaluations.

By conducting these studies early and accurately, manufacturers can minimize delays, reduce risk, and ensure compliance before regulatory submission.

At Canyon Labs, we provide a comprehensive range of services designed to meet the unique needs of medical device developers, from startups to global leaders. Our biocompatability testing capabilities include:

• Cytotoxicity testing – Detects whether materials cause cell death or damage.
• Sensitization testing – Evaluates potential for allergic or immune responses.
• Irritation evaluations identify the irritative response of the test article. Canyon Labs offers several models to assess irritation, such as intracutaneous reactivity, primary skin irritation, and ocular irritation.
• Pyrogen testing – Determines if a material or product induces fever-causing reactions in the body.
• Systemic Toxicity – May evaluate acute effects from a single exposure to multiple dose assessments over a long period of time.

Each service is performed with precision and in full alignment with ISO 10993 requirements, ensuring your products meet the highest regulatory and scientific standards.

When you partner with Canyon Labs, you gain more than a testing provider—you gain a trusted partner with a proven track record of providing GLP-compliant services. Our team of experts helps you:

• Develop the right testing strategy tailored to your device.
• Stay aligned with evolving ISO 10993 requirements.
• Avoid regulatory setbacks with accurate, validated data.
• Move from concept to market faster with comprehensive lab support.

At Canyon Labs, we raise the standard in biocompatibility testing, empowering innovators to bring safe, effective medical devices to patients worldwide.