At Toxway, we are committed to crafting meticulously detailed Biological Evaluation Plans (BEPs) that adhere to the stringent requirements of EU MDR 2017/745 and ISO 10993. Our BEPs are designed to comprehensively evaluate the biological safety of medical devices, ensuring regulatory compliance and patient safety throughout the entire product lifecycle.

Our approach begins with a thorough analysis of the medical device’s components, including materials and design, to identify potential biological risks. We evaluate these risks based on the intended use of the device and the potential exposure to patients. This process involves a detailed assessment of factors such as biocompatibility, potential for cytotoxicity, and the likelihood of adverse reactions.

We employ a risk-based methodology to ensure that our BEPs address all relevant regulatory requirements. This involves prioritizing potential risks based on their severity and likelihood, allowing us to tailor the evaluation to focus on the most critical aspects. By doing so, we help manufacturers navigate complex regulatory landscapes efficiently and effectively.

Our BEPs not only facilitate a smoother approval process by ensuring that all regulatory requirements are met but also contribute to the highest standards of patient safety and product integrity. With Toxway’s expertise, manufacturers can confidently move forward with their medical devices, knowing that they have a robust plan in place to manage biological risks and achieve regulatory compliance.

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