At Toxway, we provide thorough Gap Analysis and Standard Gap Assessment services designed to help medical device manufacturers identify and address compliance deficiencies in their development processes. Our expert team conducts detailed evaluations based on the rigorous standards of EU MDR 2017/745 and ISO 10993 guidelines, ensuring that your products adhere to essential safety and regulatory requirements.

Our process begins with a comprehensive review of your current development practices and documentation. We meticulously compare these practices against the specific criteria set forth by the EU MDR and ISO 10993. This involves assessing your quality management systems, risk management processes, and product testing procedures to identify any deviations from regulatory standards.

By pinpointing areas where your processes fall short of compliance, we provide actionable insights and practical recommendations for bridging these gaps. Our goal is to help you address any non-compliance issues efficiently, allowing you to streamline your development processes and reduce regulatory risks.

Our Gap Analysis and Standard Gap Assessments are not only aimed at ensuring regulatory adherence but also at enhancing overall product quality and safety. By implementing our recommendations, you can mitigate potential risks, improve your development workflows, and achieve a smoother and more efficient pathway to market approval. With Toxway’s expertise, you gain a trusted partner in navigating the complexities of regulatory compliance, ultimately safeguarding both product integrity and patient safety.

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