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.
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.
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.
Navigating European Medical Device Premarket Submissions
Navigating the tricky waters of regulation can be frustrating and challenging for any medical device manufacturer. When those regulations change, the prospect...
Overcoming Obstacles to Tissue Sterilization Validation: What Manufacturers Need to Know
Sterilization validation is necessary to bring tissue-based products to market. The U.S. FDA requires it, whether the device functions in vivo or in vitro, so...
The Critical Role Reprocessing Instructions Play in a Medical Device’s IFUs
Drafting Instructions for Use (IFUs) for medical devices is a delicate but critical task that supports patient safety. IFUs need to include detailed,...