Located in Marietta, GA, WuXi AppTec plays a crucial role in supporting manufacturers across all stages of product development, specializing in preclinical safety testing for medical devices. The team adheres to stringent standards like ISO, USP, ASTM, and AAMI to ensure compliance with global regulatory guidelines. At WuXi AppTec, technical specialists craft tailored study designs that align with each client's unique device, its intended use, and the target patient demographic, upholding scientific rigor and furnishing essential safety data.
Moreover, WuXi AppTec boasts a dedicated team of regulatory advisors who offer invaluable insights on test strategies, interactions with regulatory bodies, comprehensive design history file assessments, and assistance in preparing for pre-submission meetings. With a wealth of expertise at their disposal, WuXi AppTec's professionals are committed to facilitating a seamless pathway for manufacturers to navigate the intricate landscape of medical device regulations and bring their innovations to market with confidence.
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