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.
From materials characterisation to custom studies, reprocessing validations to lot release, WuXi AppTec's medical device team has you covered. We can design customised solutions for each customer and project, including:
WuXi AppTec is your trusted navigator of global regulations, like recent changes to the EU Medical Device Regulation (MDR). We consult with clients on designing optimal preclinical testing strategies for successful submission, respond to regulatory inquiries and support safety through your product lifecycle. We have developed a database of reviewer questions, which further enhances our ability to identify new trends and quickly pass this learning on to our customers.
Our active participation on global standards committees gives us unique insight into how regulators are interpreting new trends and regulatory changes. Using our consulting services provides you with direct access to the individuals at the forefront of medical device regulations, with subject matter expertise spanning custom in extractables/leachables, biocompatibility, custom in vivo models, histopathology, toxicological risk assessments, package testing, reprocessing, osteoinduction and more.
Our team of consulting experts includes:
Our wide range of testing programmes support medical device product manufacturers from design development through commercialisation.
cGMP manufacturing services are available for medical device, combination, and tissue products requiring a cleanroom or controlled manufacturing environment.
Develop strategy that addresses the data needs - submission through commercialisation - based on intended use, patient population and global distribution
WuXi AppTec is a true partner.
We stand behind the testing we do, and will support any inquiries related to our studies.