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   WuXi AppTecLaboratory

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   WuXi AppTec Medical Device Team supports manufacturers throughout the lifecycle of their products, from concept phase to...

   MoreWuXi AppTec Medical Device Team supports manufacturers throughout the lifecycle of their products, from concept phase to commercialization with unique expertise in pre-clinical safety testing. Our labs follow standards such as ISO, USP, ASTM, and AAMI to support global regulatory requirements. WuXi AppTec's technical experts develop study designs specific to our customers' device, its indication, and patient population that maintain scientific integrity and provide evidence of product safety. Our regulatory experts provide consultations on supporting test strategies, requests from regulatory agencies, design history file gap analysis, and pre-submission meeting support. In addition, we track regulatory trends through sponsor or regulatory inquiries we receive, and will adapt our strategy based on trends analyzed by our regulatory and technical experts. These trends, combined with our transparency with regulatory agencies, has aided in our approach to reprocessing cleaning and disinfection efficacy and validation studies. Above all, we stand behind our work - from test plans through clearance - responding to questions or other regulatory requests as part of the submission process. Less

   Website: medicaldevice.wuxiapptec.com

   Phone: (651) 675-2041

   Cross Streets: Between Executive Dr and Northland Dr

   Closed Now

   • Mon

     8:00 AM

     5:00 PM

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     5:00 PM

   • Fri

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   • Mon

     8:00 AM

     5:00 PM

   2540 Executive Dr St Paul, MN 55120 619.15 mi

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