WuXi AppTec is your trusted navigator of global regulations including the recent changes to the European Union Medical Device Regulations (MDR). Our experts will consult with you to design optimal preclinical testing strategies for successful submission, respond to regulatory inquiries, and support you from product development throughout your product. We have developed a database of reviewer questions, which further enhances our ability to identify new trends, and we quickly pass this learning on to our customers. WuXi Medical Device Testing offers testing services in St. Paul, MN, Atlanta, GA, and Suzhou, China.
Because our scientists are active participants on global standards committees, we have a unique insight into how regulators are interpreting new trends and regulatory changes. Our consulting services provide you with direct access to the individuals at the forefront of medical device regulations, with subject matter experts in extractables/leachables, biocompatibility, custom in vivo models, histopathology, toxicological risk assessments, package testing, reprocessing, and osteoinduction.
Our team of consulting experts includes:
- Leaders and active participants on international standards committees, including multiple ISO 10993 committees, ASTM, AAMI, and USP
- 21+ Ph.D. and post-doctorate-level scientists
- 32+ Master’s-level scientists
Preclinical Safety Consulting
Your initial consultation will identify project goals and help us understand your product. With these goals in mind, our experts will construct a test strategy report, including a full description of the device with the recommended biocompatibility and chemistry testing needed to prepare your premarket submissions. These strategies will leverage regulatory guidance documents and preexisting data, as well as any additional study proposals.
The objective is always to provide test results that are right the first time and have the highest likelihood of approval.
Regulatory Consulting Services
Biological Evaluation Test Strategy Plan
A Biological Evaluation Test Strategy is required as part of ISO 10993. Let our knowledgeable and experienced professionals help you prepare your report. Our toxicologists will recommend and summarize an ISO 10993 biocompatibility testing strategy to increase your likelihood of regulatory success.
Biological Evaluation Test Summary
Your report, prepared by a toxicologist, will summarize your ISO 10993 biocompatibility tests, including device details, standards followed, biological endpoints, and chemical characterization and provide an overview of results and device safety under intended clinical use.
Biological Evaluation with Toxicological Risk Assessment
WuXi AppTec Medical Device Testing is your partner in development and throughout your product’ lifecycle. We will provide your Toxicological Risk Assessment and ISO 10993 biocompatibility test results and expert summary with solutions to help you manage and mitigate your product’s biological risks.
Let our team help your team understand the necessary training for technical and regulatory requirements.
We will provide a comprehensive review of preexisting 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.
We have a team of experts dedicated to helping our customers execute appropriate studies to meet their needs. Your initial consultation will identify project goals and help us understand your product.
FDA Pre-submission (Pre-sub)/Q-Submission meetings are an effective way to gain key insight for your product and submission strategy. To ensure your meeting is as effective as possible, our team of experts can assist with meeting preparation and is available to participate alongside you in those meetings, either as subject matter experts or to 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), 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. For each chemical, tolerable exposure (TE) levels are determined based on relevant toxicological literature and the processes outlined in ISO 10993-17 to support device safety under intended clinical use.
WuXi AppTec Medical Device’s toxicological risk assessments are written to provide a thorough vetting of the chemicals from your extractables/leachables report. Following ISO 10993-17, our toxicologists assess each chemical to establish a margin of safety and identify whether further testing or analysis is required in order to mitigate risk.
WuXi AppTec is a true partner.
We stand behind the testing we do and will support any inquiries related to our studies.