Biocompatibility testing is a critical aspect of medical device development, ensuring that products are safe and effective for human use. Regulatory authorities such as the FDA, ISO, and CDSCO mandate rigorous testing to evaluate potential risks associated with materials used in medical devices. Proper biocompatibility assessment prevents adverse biological reactions, ensuring patient safety and compliance with global regulatory standards.
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At Bioexcel, we provide end-to-end biocompatibility testing solutions tailored to meet the requirements of ISO 10993-1:2018, FDA, and EUMDR. Our services include:
Explore real-world case studies showcasing Bioexcel’s biocompatibility testing expertise and how our solutions have helped clients meet regulatory standards and achieve market approval.
Solution by Bioexcel
Bioexcel provides a streamlined approach to biocompatibility testing, ensuring compliance with global standards while minimizing time-to-market for medical device manufacturers. Our solutions include:
Customized test plans based on device risk classification
Expert consultation on regulatory compliance
Comprehensive report generation and regulatory submission support
Ensure the safety and regulatory compliance of your medical device with Bioexcel's biocompatibility testing services. Contact us today to discuss your testing requirements!
Biocompatibility testing evaluates how a medical device material interacts with biological systems to ensure safety for human use.
The primary standard is ISO 10993-1:2018, along with FDA, EUMDR, and CDSCO requirements.
The timeline depends on the complexity of the device and required tests but typically ranges from a few weeks to months.
Yes, we provide complete support for documentation and regulatory submissions.
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