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.
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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:
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 endpoints with chemical characterization and risk 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 and 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.
Packaging Pitfalls Medical Device Manufacturers Cannot Ignore
As stated in the international packaging standard, ISO 11607, designing and developing a packaging system for terminally sterilized medical devices is a...
Safe & Compliant: Mitigating Risks After Device Modifications
The medical device regulatory environment is continuously evolving. As regulatory body expectations become more demanding, manufacturers need to evaluate the...
E/L Testing Isn’t What It Used to Be
Medical device biological safety evaluations have advanced significantly over the last ten years, and regulatory requirements are quickly evolving as well....