At Toxway, we excel in designing and overseeing biocompatibility studies to ensure that medical devices meet the rigorous safety standards outlined in ISO 10993 and ISO 18562. Our comprehensive approach begins with the development of tailored study designs that are meticulously crafted to address the specific materials, design, and intended use of each medical device. We focus on identifying and evaluating all potential biological risks associated with the device, ensuring that our testing protocols are both thorough and relevant.

Our process includes a detailed assessment of the device’s interaction with biological systems, including in vitro and in vivo testing as required. By employing a risk-based approach, we ensure that the study design is aligned with the latest regulatory guidelines and industry best practices. This involves selecting appropriate test methods, determining sample sizes, and defining exposure conditions to accurately simulate real-world use.

Continuous monitoring is a critical component of our service. We oversee each phase of the study to ensure compliance with regulatory standards and to maintain the highest levels of accuracy and reliability. Our team tracks progress, reviews data in real-time, and makes necessary adjustments to address any emerging issues. This proactive approach helps in identifying and mitigating potential risks early in the process.

By integrating robust study design with meticulous monitoring, we ensure that your medical devices undergo a comprehensive evaluation for biocompatibility. This process not only helps in meeting regulatory requirements but also plays a crucial role in safeguarding patient safety and facilitating successful regulatory approval. Our commitment to excellence ensures that your devices are both safe and effective, enhancing their market readiness and overall reliability.

For more information about our services or to request a consultation, contact us at info@Toxway.com