To assess your biological risk, every medical device manufactured is required to complete a biocompatibility analysis. Whether your device requires complete chemical characterization to support a toxicological risk assessment, or you need risk mitigation to address a regulatory finding, WuXi AppTec can help. Our chemistry and toxicology experts help you design preclinical testing strategies that adhere to the most current standards and follow regulatory guidance from Japan, China, EU and the U.S. – experts who actively lead and participate in international standards committees including ISO, ASTM and AAMI, providing you with their unique perspective into the “why” behind the standards and how that may lead to interpretation among different regulatory bodies.
We anticipate emerging global regulatory hurdles and recommend test plans to accommodate for these unique and changing expectations. We also have a proprietary database of reviewer questions that enhances our ability to identify new trends and allows us to pass them on to our customers.
WuXi AppTec Medical Device Testing Consulting Services provides you with direct access to experts who are at the forefront of medical device standards, offering up subject matter expertise in:
Toxicological Risk Assessments
FDA Pre-submission/Q-submission Support
Test Plan Strategy
WuXi AppTec is a trusted partner who stands behind the testing we provide and supports all inquiries related to our studies. Our medical device testing services are offered in St. Paul, MN, Atlanta, GA, and Suzhou, China.
Preclinical Safety Consulting
During your initial consultation we will identify project goals for your product and build a test strategy, including a full description of the device, recommended biological endpoints, and the chemistry testing needed to prepare your regulatory submissions. These strategies will leverage regulatory guidance, relevant data and any additional study proposals. We also provide you with safety data and justifications that are consistent with the most current guidance to increase your likelihood of regulatory success.
Regulatory Consulting Services
Biological Evaluation Test Strategy Plan
Let our toxicologists help you recommend and prepare your biocompatibility testing strategy to increase your likelihood of regulatory success, in accordance with ISO-10993.
Your report will contain complete chemical characterization and a toxicological risk assessment for your device. Details will include all biological endpoints that support the safe interaction between your medical device or material and a patient’s tissue, cells or bodily fluid. The primary goal of the biological evaluation is to identify potential biological risks to the patient.
Let our team of scientists/experts help your team understand the necessary training for technical and regulatory requirements.
We provide a comprehensive review of existing data to identify gaps to help you meet current ISO 10993 standards. In your report, we will assess impact and design a plan to address those gaps.
Our team of scientific experts is dedicated to helping our customers execute appropriate studies to meet their needs. Your initial consultation will identify project goals and help us clearly understand your device.
U.S. FDA pre-submission (pre-sub)/q-submission meetings are an effective way for regulators to gain early exposure to your product and provide feedback on your submission strategy. To ensure your meeting is as effective as possible, our team of experts can help you prepare and, if you choose, participate alongside you in these early meetings. We can serve as subject matter experts or support scientific justifications, strategy, or study designs.
Regulatory Inquiry Support
Regulatory and technical support are available to address inquiries from various regulatory agencies e.g., Additional Information requests (A.I.s) and remediation, on day one and across the lifespan of your product.
Toxicological Risk Assessment
The toxicological risk assessment evaluates the safety of chemicals identified through chemical characterization and your extractables/leachables report. For each chemical at or above the analytical evaluation threshold (AET), tolerable intake (TI) levels, exposure dose estimations and margins of safety are determined based on relevant toxicological literature and the processes outlined in ISO 10993-17. Toxicological risk assessments will also identify where further testing or analysis is required in order to mitigate risk.