Medical Device Testing
The medical device regulatory environment is constantly evolving. The experts at WuXi AppTec are here to guide you. We provide world-class, integrated, testing solutions to enable our clients to transform their ideas into life-changing healthcare solutions for patients and caregivers. We are committed to delivering the highest level of lab testing to make that vision a reality—for companies big and small.
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:
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.
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.
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.
The current regulatory environment has created both opportunities and setbacks for medical device companies as they work toward obtaining regulatory approval...
As regulatory expectations intensify, medical device testing can require more time and budget to satisfy standards. The testing plan decisions you make early...
Manufacturers are not the only ones facing challenges due to the updates to ISO 10993 and other recent regulatory changes. The evolving standards are also...