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+1 (888) 794-0077 WuXi Ordering System Contact Us Services Testing Chemical Characterization Toxicological Risk Assessment Biocompatibility In Vivo Small Animal Models Antimicrobial Efficacy Testing Custom Preclinical Medical Device Studies Suzhou Large Animal Research Facility Package, Product & Environment Validation Testing Packaging Validation Cleaning & Sterilization Validation Microbiology HCT/P Sterility Assurance and Lot Testing Combination Products Consulting Services Regulatory/News Events Blog Trade Articles Digital Learning Quality Certificates Company Testing Locations Meet Our Experts Talk to an Expert Select Page Medical Device Testing at WuXi AppTec The medical device regulatory environment is constantly evolving. Our experts provide world-class, integrated, testing solutions enabling clients to transform ideas into life-changing healthcare solutions for patients and caregivers. We focus on delivering the highest level of lab testing services, making our clients vision a reality. What You Need to Know Improving Patient Lives Together To support your products in today’s complex global marketplace, you need an approach that is tailored to your unique product and distribution strategy. WuXi AppTec has supported hundreds of thousands of devices with the strategies and testing needed to gain market access, avoid costly delays and support changing requirements throughout a product’s lifecycle. How do we do this? By focusing our efforts on the following three areas of robust chemistry, active leadership, and strategic partnerships. Robust Chemistry We’re the chemistry gold standard with the only program committed to doing complete characterization the first time and every time. We meet biocompatibility systemic risk and chemical characterization endpoints at a level that is markedly higher than our closest competitor. Active Leadership We share our knowledge with the FDA on how to approach Biological Evaluations based on International Standards because we serve on standards committees and track regulatory inquiries and trends. It’s what gives us the inside track to be proactive partners that anticipate change. Strategic Partnership From development through commercialization, we’re your full-service partner and strategic consultant. We’re a true extension of your team. White Paper: Unknowns are Unacceptable™ Our risk-based approach to medical device, chemical characterization and toxicological risk assessment can help you navigate the latest FDA requirements and get your product to market faster. Read More Partnering for Global Medical Device Success From materials characterization to custom studies, reprocessing validations to lot release, WuXi AppTec’s medical device team has you covered. We can design customized solutions for each customer and project, including: Advising clients regarding ongoing regulatory changes and supporting interaction with regulatory bodies Leading scientific discovery and guiding study design to achieve optimal results Applying our expertise across medical devices, biologics and combination projects ISO 10993-1: Spotlight on chemical characterization Our Senior Director of Analytical Chemistry and Regulatory Toxicology, Sandi Schaible, is an international delegate for ISO 10993 Part 18. Here, she explains the recent changes. Beyond Standard Testing: Exploring the Benefits of Custom Preclinical Solutions Apr 5, 2024 | Manufacturing , MDR , Medical Device , Medical Device Testing , Regulatory In an increasingly complex world, one size rarely fits all. In most preclinical studies, testing services can be bought off-the-rack and fulfill all the needs... What Manufacturers Need to Know About the MDR Deadline Extension Apr 5, 2024 | General , Manufacturing , MDR , Medical Device Testing , Regulatory In March 2023, the European Parliament handed medical device manufacturers some breathing room when it amended the Medical Device Regulation (MDR) to allow... Understanding ‘Assumed Release’ in ISO 10993-17:2023 Apr 5, 2024 | General , MDR , Medical Device Testing , Regulatory , Technical Expertise The latest update to ISO 10993-17:2023 introduces significant changes to how medical device manufacturers and toxicologists can estimate and incorporate... WuXi AppTec Corporate WuXi AppTec Laboratory Testing Division Quality Certificates Ordering Portal Our Blog Careers Testing Locations Contact Us © 2023 WuXi AppTec | Privacy Policy | Terms of...