Improving Patient’s Lives — TogetherTo 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 assessment 80–85% of the time.
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, and true extension of your team.
Partnering for Global Medical Device SuccessFrom 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 characterizationOur Senior Director of Analytical Chemistry and Regulatory Toxicology, Sandi Schaible, is an international delegate for ISO 10993 Part 18. Watch her explain the recent changes.
Our medical device preclinical safety consulting draws on more than 25 years of experience to support the overall safety of your device.
Our wide range of testing programs support medical device product manufacturers from design development through commercialization.
cGMP manufacturing services are available for medical device, combination, and tissue products requiring a cleanroom or controlled manufacturing environment.
Robust environmental monitoring program includes information to support process controls through sample collection, microbial testing and trending data.
A wealth of knowledge was gained from a historic data review of radiation dose verification failures. Our experts highlight the importance and application of this data set as well as its benefit to device manufacturers.