WuXi AppTec - MN US Laboratory

Overview

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 Approach

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.

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, and true extension of your team.

Standards & Methodologies

Preclinical Safety testing for Medical Devices following regulatory standards and methodologies

Qualifications, Certifications, Accreditations & Licenses

AATB
ISO/IEC 17025
EMA
State of FL Tissue Bank Certificate
FDA
State of MD Tissue Bank Permit
State of CA TIssue Bank License
State of NY Provisional Licence for Tissue Banks
ISO 13485
ISTA

Lab Gallery

Industries Served

WuXi AppTec has not posted the industries they service.

Testing Types

WuXi AppTec has not posted the types of testing they provide.

Publications

WuXi AppTec has not posted any publications.

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