WuXi AppTec - Global contract research outsourcing provider, serving the pharmaceutical, biotech and medical device industries

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.

  1. Robust approach. We're the chemistry gold standard, with the only programme committed to doing complete characterisation the first time and every time. We meet biocompatibility systemic endpoints with chemical characterisation and risk assessment 80-85% of the time.
  2. 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.
  3. Strategic Partnership. From development through commercialisation, we're your full-service partner and strategic consultant, and true extension of your team.

Partnering for Global Medical Device Success

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:

  • 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.

Consulting Services

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.

Proven Expertise

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:

  • Leaders and active participants on international standards committees, including multiple ISO 10993 committees, ASTM, AAMI and USP
  • 21+ Ph.D. and post-doctorate-level experts
  • 32+ master's-level scientists.

Regulatory Consulting Services

  • Biological Evaluation Test Strategy Plan
  • Biological Evaluation Test Summary
  • Biological Evaluation With Toxicological Risk Assessment
  • Education
  • Gap Analysis
  • Initial Consultation
  • Pre-submission/Q-Submission Meeting
  • Regulatory Inquiry Support
  • Toxicological Risk Assessment.

Testing

Our wide range of testing programmes support medical device product manufacturers from design development through commercialisation.

  • Materials Characterisation
  • Toxicological Risk Assessment
  • Biocompatibility
  • In Vivo Small Animal Models
  • Package Testing & Validation
  • Product and Environment Validation
  • Microbiology
  • Services for Tissue-Based Products
  • Combination Products
  • Testing Facilities.

Manufacturing

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

One Team, One Strategy

Develop strategy that addresses the data needs - submission through commercialisation - based on intended use, patient population and global distribution

  • Understand the goal
  • Customise the scope
  • Implement the project
  • Data support for product safety.

WuXi AppTec is a true partner.

We stand behind the testing we do, and will support any inquiries related to our studies.

Products and Services

Contact Details

WuXi AppTec
Tel: +1 888 794 0077
Email: [email protected]
URL: medicaldevice.wuxiapptec.com

Throughout the device development lifecycle, regulatory submission and lot release, we offer a spectrum of services to support product commercialisation. Image courtesy of WuXi AppTec.
One Team, One Strategy: Develop strategy that addresses the data needs – submission through commercialisation – based on intended use, patient population and global distribution. Image courtesy of WuXi AppTec.
Regulators will look for extraction conditions that demonstrate a device has been challenged. Image courtesy of WuXi AppTec.
Selecting a laboratory testing partner with expertise in complete chemical characterisation is critical. Image courtesy of WuXi AppTec.
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