NAMSA建立于1967年,是全球医疗器械安全性和有效性研究领域中公认的先驱。早在美国FDA 1976年对医疗器械建立比较完整的监管法规之前,就在美国市场中为科学家对医疗器械安全性和有效性研究提供各种实验室测试研究服务。

如今NAMSA为医疗器械厂商提供全程产品开发研究、风险管理、和质量管理的实验室数据测试、临床研究计划实施和法规的咨询服务。服务的领域涉及几乎所有医疗器械产品,例如心血管、骨科、眼科、牙科、诊断试剂等。

我们的服务包括:法规和质量体系咨询  (510(k), CE Mark,FDA审查, 全球质量系统整合等);研究和开发支持 (材料表征,风险评估等);非临床测试(生物相容性测试,功效性动物实验等);临床研究 (临床评估报告,欧盟和美国临床实验,IVD临床实验等);上市后支持 (灭菌验证,灭菌指示剂产品) ...

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NAMSA专家介绍 + MORE
  • Jennifer Mischke
    Jennifer Mischke is Director of Biostatistics and Data Management for NAMSA, a medical device CRO providing full-service support throughout the product development process. Jennifer is responsible for a team of statisticians, data managers, and trial administrators who handle all aspects of data management as well as statistical aspects of the design, execution, and analyses of clinical studies. Jennifer has authored numerous regulatory submissions, manuscripts, presentations, and other publications, with a focus on statistics and scientific considerations. With 15 years in clinical research, Jennifer’s background includes experience on all phases of clinical studies, including pre-clinical, clinical, and post-market studies.
  • Dr. Joseph Carraway
    Dr. Joseph Carraway, Scientific DirectorLaboratory Services at NAMSA possesses 15 years of experience in medical device testing and evaluation with over 29 years in clinical medicine and surgery; biomedical science, surgical models and testing procedures; program and facilities evaluation; and regulatory affairs.
  • An Liu 刘安
    刘安先生是NAMSA中国区总经理。2012他负责建立了NAMSA在中国的外商独资企业,目前负责NAMSA在中国及亚太地区的业务。刘安先生也给众多医疗器械厂商提供美国FDA和中国FDA法规咨询,包括生物安全性评价,临床前研究及临床试验。他拥有10多年的医疗器械临床试验,生物统计,临床数据管理,和法规方面的工作经验。负责NAMSA中国业务之前,刘安先生曾任职NAMSA临床数据管理和生物统计总监,美敦力临床统计经理......
  • Brian Edwards
    Brian Edwards, Senior Medical Research Manager, Regulatory joined NAMSA in 2014 and is based in Minneapolis Minnesota. He brings over 20 years of experience in the medical device industry, with expertise in the design and analysis of clinical trials, biostatistics, development of global regulatory strategies and submissions, quality systems, and interactions with regulatory bodies. His specific medical device experience includes work with spinal orthopedic implants and instrumentation, active implantable middle ear devices, interventional cardiology devices, electrotherapy devices, cardiac rhythm management devices, and related accessories. Prior to joining NAMSA, he served as Director of Regulatory Affairs at Zimmer Spine and also held senior regulatory and quality positions at Otologics, Compex and Medtronic with experience managing global regulatory market approvals for Class II and III products in the United States, European Union, Canada, Latin America and Asia. Brian holds a B.S. in Chemical Engineering, a M.S. in Biomedical Engineering from the University of Minnesota, and a M.S. in Biostatistics from the University of California, Los Angeles.
  • John Shen
    John Shen,首席咨询及生物统计部经理,NAMSA 美国 John leads a team of experienced biostatisticians to provide expertise on the statistical design of protocols, execution and analysis and reporting of clinical studies. John has more than 10 years biostatistics experiences in pharmaceutical drug and medical device industries with strong and diverse therapeutic background. He has authored and coauthored many peer- reviewed statistical and medical publications, presentations and regulatory submissions. His professional experiences cover all phases of clinical trials including early phases and preclinical, clinical, post-approval and post-market and in vitro diagnostics. John earned his medical degrees (M.D., M.S.) from Hebei Medical University and Capital Medical University in China and his Master of Science degree in statistics from the University of Georgia.
  • Dr. Zhaohui Li 李朝辉
    Dr. Zhaohui Li is Director of APAC Sales, NAMSA China. Zhaohui most recently worked in TUV SUD Singapore lab as a GLP Study Director. He managed more than 150 GLP safety and efficacy studies, including protocol development, study execution, and final report. Zhaohui had technical expertise in ELISA, bone and muscle implant, intradermal injection, IV IP injection and many other hands-on lab experiences. Zhaohui was also involved in market development, training, speaking, and sales team development for TUV SUD China testing business effort. Before TUV SUD, Zhaohui worked in National Cancer Center Singapore as a research fellow, where he managed a lung cancer clinical study; worked in National University of Singapore as a research officer studying on neurodegenerative disease. Zhaohui obtained his Ph.D. in neuroscience from National University of Singapore and BS in Biochemical Pharmaceutics from Jilin University, China.​
  • Vincent Legay
    Dr. Vincent Legay, Manager of the European department for Regulatory, Quality, Validation & Biological Safety Services with NAMSA, holds a Ph.D. in microbiology and cellular biology, and an MBA. Along with his expertise in Medical Device Life-Cycle, Vincent has more than 10 years of experience in the areas of Sterilization, Biocompatibility, Risk Management, Clinical Evaluation Reports, Clinical Studies, Regulatory pathways and Quality Systems. During his career, he has held a number of positions including laboratory management, GLP Study Director, Consultant, and Project Manager. Today, Vincent provides Regulatory support to manufacturers together with his team of experts able to support manufacturers in all areas such as Sterilization, Biocompatibility, Risk Management, Clinical Evaluation Reports, Clinical Studies, Regulatory pathways and Quality Systems.
  • Dr. Donald F. Palme
    Donald F. Palme II, Ph.D., Medical Research Scientist: Don has more than 20 years of experience in the medical device industry including materials, device and biological biocompatibility testing. Specializes in designing and directing pre-clinical in-vivo testing including safety, efficacy and materials biocompatibility. He has a Ph.D. in Immunology and Pathology and M.S.and B.S. in Microbiology.
  • Janette Benaddi
    Janette Benaddi is the Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a breadth of services form preclinical to post market activities throughout the medical device product development cycle.
  • Mike Bravo
    Mike Bravo,NAMSA临床前和功能研究总监.Mike have the privilege to work with an experienced staff of preclinical experts and over 750 global Associates across all NAMSA disciplines (including regulatory, biostatistics, clinical, and biocompatibility) to develop and implement global preclinical strategies for bringing a medical device to market. By leveraging other disciplines early within the preclinical sphere, timelines and budgets can be reduced. This is done by utilizing the unparalleled breadth of services NAMSA offers across the medical device product development cycle--an extensive team of experienced, dedicated, cross-functional staff who are committed to serving clients, and adept at finding ways to get products to market faster and with regulatory rigor.​