At Toxway, we excel in providing Risk-Based Biological Evaluations, employing a predicate device approach to enhance the efficiency and effectiveness of the compliance process for medical devices. This sophisticated method involves using data and findings from previously approved devices that are similar to your product, enabling us to assess the biological safety of your device with greater precision.

Our approach starts by conducting a comprehensive comparison between your device and existing predicate devices that have already met regulatory standards. We analyze their biological evaluation data to identify relevant safety profiles, potential risks, and performance characteristics that align with your product. This allows us to leverage existing knowledge and reduce the need for extensive new testing.

By focusing on pertinent biological risks and establishing parallels with established devices, we streamline the evaluation process and ensure that your device complies with stringent regulatory requirements set by EU MDR 2017/745 and ISO 10993. Our risk-based evaluation not only addresses critical safety concerns but also provides a more targeted and efficient approach to demonstrating compliance.

This method significantly accelerates the time-to-market for your medical device by reducing the duration and cost of the testing process. At the same time, it maintains high standards of quality and safety, ensuring that your product meets both regulatory expectations and patient safety standards. With Toxway’s expertise, you benefit from a streamlined, cost-effective evaluation process that supports your product’s successful entry into the market while upholding rigorous safety and compliance standards.

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