Our medical device testing programs are developed in compliance with global regulatory requirements and can be customized to fit your needs at any point throughout the product development lifecycle. WuXi AppTec’s industry-recognized scientists have the expertise and experience to support your decision making – from the development phase all the way through commercial release.
Leading the Medical Device Testing Field
To enable our clients to be in the best position to get their product approved, WuXi AppTec specializes in offering individualized testing program guidance and pinpoint insights that come from our focus on the regulatory environment. We diligently monitor the regulatory arena and a number of our industry-recognized experts participate directly in international standards committees.
Testing Programs For Medical Devices
WuXi AppTec continually expands and updates our services menu in response to ever-changing regulatory requirements, providing testing programs designed to fit your needs — from research and development to lot release.
| Biocompatibility
Microbiology |
Materials Characterization
Sterilization Management |
Risk Assessment
Preclinical Studies |
Risk Assessments
One key to regulatory success today is the ability to link all of your data by means of risk assessment. WuXi AppTec’s experts can help you not only plan and design the right study programs, but also provide thoughtful risk assessment evaluations at all stages of your product development.
Faced with the daunting challenges of getting a product to market, device manufacturers can look to WuXi AppTec – with our deep understanding of regulatory expectations – for key services and expert guidance in designing optimal study programs that will make the development process easier and faster.
WuXi AppTec sends out a periodic e-newsletter to our contacts in the combination product/medical device industry. To access previous issues, click here.
Contact
WuXi AppTec
2540 Executive Drive
Mendota Heights
MN 55120
Tel: 651.675.2000
Email: Heidi.Shaw@wuxiapptec.com
URL: www.wuxiapptec.com