WuXi AppTec is your trusted navigator of global regulations, like recent changes to the European Union Medical Device Regulation (MDR). We consult with clients on designing optimal preclinical testing strategies for successful submission, respond to regulatory inquiries and support safety through your product lifecycle. We have developed a database of reviewer questions, which further enhances our ability to identify new trends and quickly pass this learning on to our customers.
Our active participation on global standards committees gives us unique insight into how regulators are interpreting new trends and regulatory changes. Using our consulting services provides you with direct access to the individuals at the forefront of medical device regulations, with subject matter expertise spanning custom in extractables/leachables, biocompatibility, custom in vivo models, histopathology, toxicological risk assessments, package testing, reprocessing, osteoinduction and more.
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 experts
- 32+ Master’s-level scientists
Preclinical Safety Consulting
An 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, which includes a full description of the device, with the recommended biocompatibility and chemistry testing to assist in preparing premarket submissions. These strategies will leverage regulatory guidance documents and preexisting data, as well as any additional study proposals designed to assess safety.
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
ISO 10993 requires this report, prepared by a knowledgeable and experienced professional. Our toxicologists will recommend and summarize an ISO 10993 biocompatibility testing strategy, including device details, standards followed, biological endpoints, chemical characterization and other elements, with the intention of increasing your likelihood of regulatory success.
Biological Evaluation Test Summary
This report, prepared by a toxicologist, will summarize the ISO 10993 biocompatibility testing performed, including device details, standards followed, biological endpoints, chemical characterization, etc., and provides an overview of results and device safety under intended clinical use.
Biological Evaluation With Toxicological Risk Assessment
This report includes the Toxicological Risk Assessment and ISO 10993 biocompatibility test results and summary.
Training for technical and regulatory requirements.
A comprehensive review of preexisting data to identify gaps when compared to current ISO 10993 standards. This report 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. An 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 are 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).
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 Laboratory Testing Division Medical Device Platform’s toxicological risk assessments are written to provide a thorough vetting of the chemicals from an 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.