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.
Response to COVID-19: We’re Here For You
As the world faces challenging times, we remain true to our promise to serve and support our customers. We are here to help.
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.
Webinar: Biocompatibility Evaluation of Medical Devices for Global Registration
When preparing your medical device for a global submission, there are many factors to consider from developing a testing plan to keeping up with regulatory...
Extraction Techniques: Designing the Right Studies to Get the Answers You Need
Having a clear understanding of the chemistry required for regulatory submission is not an easy feat. Chemistry background knowledge is crucial when making...
AATCC TM 100-2019: Assessment of & What It Means for Medical Textiles
Staying up to date on regulatory requirements and industry standards can be a challenge with ever-evolving expectations. However, keeping a close eye on...