美国美德思有限公司(MEDevice Services, LLC)是一家总部位于美国，并经美国政府批准专业从事医疗法规咨询服务的机构。作为全球最具影响力的医疗产品法规事务专业人员协会(Regulatory Affairs Professionals Society, RAPS)、美国医疗仪器促进协会(Association for the Advancement of Medical Instrumentation, AAMI)、以及美国质量学会(American Society for Quality, ASQ)等国际组织的成员，我们致力于向全球医疗领域提供最专业的法规咨询服务。
我们的专家团队将会协助您的医疗器械产品满足美国、欧盟、加拿大、澳大利亚、中国等相关国家的法规要求，越过最后的法规屏障，顺利进入全球最重要的医疗器械市场。
•美国FDA 510(k)认证、美国FDA授权代理人(U.S.FDA Agent)、企业FDA注册登记、产品FDA列名、21CFR820 (QSR)
•欧盟ISO 13485、CE认证
•加拿大CMDCAS、加拿大卫生部医疗器械执照申请
•澳大利亚卫生部(TGA)医疗器械执照申请
•中国食品与药品监督管理局SFDA医疗器械注册
同时我们能协助您寻找优秀的海外贸易伙伴拓展您的海外业务。
MEDevice Services, LLC is a professional medical regulatory affairs consulting company, headquartered in USA. As the membership of the most influential global organizations such as Regulatory Affairs Professionals Society (RAPS), (Association for the Advancement of Medical Instrumentation, AAMI), (American Society for Quality, ASQ), etc., we devote ourselves entirely to providing the most professional regulatory consulting services to worldwide medical field.
In today's global marketplace, the path to launching medical devices, in vitro diagnostics or combination products into the market can be long and complex. It is a highly regulated process and strict governmental requirements demand a trusted advisor who can simplify and shorten the path for you. The time-to-market can mean the difference between financial success and failure.
At MEDevice Services, LLC, your success is our first commitment. We understand how to make your product launch more efficient, saving you time and money. We can help you quickly get government approval and minimize your business risk by ensuring your medical products follow all the required approval processes.
Our breadth and depth of knowledge, experience, and expertise with a variety of medical products and technologies enable us to develop creative approaches to reach your goals of successfully introducing your products in the worldwide marketplace such as USA, EU, Canada, Australia, China, etc.
•U.S. FDA 510(k), U.S. FDA Agent、Establishment Registration, Device Listing, 21CFR820 Quality System Regulation (QSR)
•ISO 13485、CE Mark
•Canadian Medical Devices Conformity Assessment System (CMDCAS), Health Canada Medical Device License
•Therapeutic Goods Administration (TGA) Medical Device License in Australia
•State Food and Drug Administration (SFDA) medical device registration in China
We can support your regulatory needs as you grow.
