At Toxway, we provide meticulous Biological Evaluation Reports (BERs) that offer an exhaustive documentation of the safety and compliance of medical devices, adhering to the stringent requirements set forth by EU MDR 2017/745 and ISO 10993. Our BERs are crafted to provide a detailed and transparent assessment of your device’s biocompatibility, ensuring that every aspect of the evaluation process is thoroughly documented.

Our BERs encompass a comprehensive review of all relevant testing conducted, including in vitro and in vivo studies, as well as the results of any toxicological risk assessments. We meticulously detail the methodologies employed, the test results obtained, and the subsequent risk evaluations, providing a clear and structured account of how the device meets safety and regulatory standards.

In addition to documenting the outcomes of the biocompatibility studies, our BERs include a rigorous analysis of the safety justifications made throughout the evaluation process. This includes a thorough examination of potential biological risks, the rationale behind the testing procedures, and the conclusions drawn regarding the device’s safety profile.

Our reports are designed to facilitate both pre-market submissions and ongoing regulatory audits. We ensure that the BERs provide clear, concise, and well-organized documentation that supports the approval process and demonstrates compliance with global regulatory standards. By prioritizing precision and adherence to established guidelines, our BERs help streamline regulatory approvals and reinforce the commitment to patient safety.

With Toxway’s BERs, you can be confident that your medical device is supported by robust and reliable documentation, ensuring a smoother path to market and ongoing regulatory compliance.

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