WuXi Medical Device Testing
The medical device regulatory environment is constantly evolving—let WuXi AppTec be your guide. 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 level of expert lab testing needed to make that vision a reality—for companies big and small.
Preparing for MDR:
Don’t Forget about Class I Reusable Devices
Medical device manufacturers are busy preparing for the about MDR and Class III device changes. As you work through your portfolio and sort your products into families, you’ll face many tough decisions. You need to be aware of some key changes to the regulations.ead More
Improving Patient’s 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 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.
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
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. Watch her explain the recent changes.
Method transfers are integral to getting a product to the manufacturing floor. The transition of information and processes from an original equipment...
The new EU regulations will require much more documentation and perhaps some new evaluations from medical device manufacturers. An expert explains how to...
The sudden closure of a medical device sterilization plant in February and a second plant closure planned for later this year have raised questions about the...