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WuXi AppTec Laboratory Testing Division Medical Device Platform

To support your product’s safety in today’s complex global marketplace, you need an approach that is tailored to your unique product and distribution strategy. WuXi AppTec partners with medical device manufacturers, guiding you through the often complicated regulatory process to successfully execute your project. We have 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. Your success is our success. WuXi AppTec works as a seamless extension of your team to develop a comprehensive program that will meet the endpoints you need to support your product’s safety, while avoiding requests for additional information and other potential regulatory setbacks. Whether you require minimal testing or a complex customized program, our team will design the optimal strategy for your product, leveraging vast experience testing a wide range of devices and knowledge gained from leading and serving on international standards committees. We are continuously refining our offering to align with the needs of the global market. Currently, we are expanding our capabilities and opportunities for customers around the world with the addition of a new state-of-the-art facility, currently under construction, in the industrial hub of Suzhou, China. Follow our blog for the latest information.

Consulting

  WuXi’s Medical Device Platform draws on 25 years of experience to provide preclinical safety consulting to support the overall safety of your device.

Testing

  We have a wide range of testing programs to support medical device product manufacturers from concept to commercialization.

Manufacturing

  cGMP manufacturing services are available for medical device, combination and tissue products requiring a cleanroom or controlled manufacturing environment.

Partnering for Global Medical Device Success

As your partner, our goal is to foster a collaborative engagement in which we work as an extension of your own internal team. We are able to leverage our diverse scientific, technical and regulatory expertise to help you achieve your goals. We are an integrated platform with the flexibility to design customized solutions for each customer and project, and the ability to easily scale to commercialization for both testing and manufacturing. From materials characterization to custom efficacy studies, reprocessing validations to lot release, WuXi AppTec’s medical device team has you covered.
  • Counsel clients based on upcoming regulatory changes
  • Actively participate in scientific discovery
  • Support our clients through interaction with regulatory bodies
  • Guide study design to achieve optimal outcomes
  • Understand intent & focus of global regulatory groups
  • Apply a broad base of regulatory experience across medical devices, biologics, & combination products

EVENTs

2018 AATB Annual Meeting
October 9 – 12
Dallas, TX
BIOMEDevice San Jose 2018
December 5 – 6
San Jose, CA
DeviceTalks West
December 11 – 12
Costa Mesa, CA