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Services and Expertises - AcmeBiotechs Consulting Co.
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Quality Management System Counseling. United State Food and Drug Administration (U.S. FDA). Establishment Registration and Device Listing. Premarket Notification, 510(k). Investigational Device Exemption, IDE. Premarket Approval, PMA. European Union CE Marking. CE marking certification, MDD Technical Construction File. EU Risk management Report. Taiwan Food and Drug Administration (TFDA). Taiwan Quality System Documents (QSD). Skin Irritation in Rabbit, ISO10993-10. Eye Irritation in Rabbit, ISO10993-10.
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Knowledge Center - AcmeBiotechs Consulting Co.
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Quality Management System Counseling. To help our clients better understand medical device regulations and how we can assist them, we provide brief introductions for regulations in different countries and the links of administrations or agencies related to medical device regulations. We will continuously update information and news related to medical device regulations. Contact us for any questions on medical device regulations. We are here to help you access global market. Shown below ar...
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Services and Expertises - AcmeBiotechs Consulting Co.
http://acmebiotechs.weebly.com/regulatory-consulting.html
Quality Management System Counseling. Premarket Notification, 510(k). Establishment Registration and Device Listing. Investigational Device Exemption, IDE. Premarket Approval, PMA. Quality System Documents (QSD). MDD Technical Construction File. Create a free website. Create your own free website. Start your own free website. A surprisingly easy drag and drop site creator. Learn more.
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Team - AcmeBiotechs Consulting Co.
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Quality Management System Counseling. Mr Hsienkun (Michael) Lee. Consultant, Department of Medical Research, Mackay. Committee Member, "Standard Testing and Certification. Ndustry Product” Committee. Speaker, Plastics Industry Development Center. Device testing and Industrial Developing Manager,. R&D vice manager and product manager, Biotech-One Co. Ltd. Veterinarian, Taipei City Animal Protection Office. President, Taipei Ai-Sheng Animal Hospital. Veterinarian, Taipei Southeast Animal Hospital.
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Services and Expertises - AcmeBiotechs Consulting Co.
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Quality Management System Counseling. Create a free website. Create your own free website. Start your own free website. A surprisingly easy drag and drop site creator. Learn more.
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Team - AcmeBiotechs Consulting Co.
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Quality Management System Counseling. At AcmeBiotechs Consulting, we believe that a professional and enterprising team is the foundation of our company and business. We provide our client an experienced team, with multi-discipline background in regulation and science, to support clients on their ways to access global market in medical device industries. We take ourselves as client's partner to grow in the rapidly changing global market. Learn More about Our Team. Create a free website.
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Team - AcmeBiotechs Consulting Co.
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Quality Management System Counseling. Mr Hsien-Kun (Michael) Lee. University of Science and Technology, B.S. in. Taipei Medical University, M.S. in Biomedical Materials and Tissue Engineering. Taipei Medical University,. MS in Medical Laboratory Science and Biotechnology. MS in Institute of. Bachelor of of Biomedical Science and Engineerin. Create a free website. Create your own free website. Start your own free website. A surprisingly easy drag and drop site creator. Learn more.
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Partners - AcmeBiotechs Consulting Co.
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Quality Management System Counseling. Create a free website. Create your own free website. Start your own free website. A surprisingly easy drag and drop site creator. Learn more.
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Mission and Vision - AcmeBiotechs Consulting Co.
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Quality Management System Counseling. Our Mission and Vision. AcmeBiotechs Consulting is managed based on. Ldquo;Enthusiasm, Profession, and Conscientiousness”. Ldquo;Advancement, Honest, Credibility, and Practice”. Is our guiding principle. With innovation and budget consideration in our mind, we assist manufacturers on developing their medical device and IVD, and help them to commercialize products worldwide. Create a free website. Create your own free website. Start your own free website.
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Regulations - AcmeBiotechs Consulting Co.
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Quality Management System Counseling. For imported medical devices, their initial registrations can be divided into three conditions:. Devices that are approved for marketing abroad,. Class I devices that are not certified abroad,. Class II and III devices that are not certified abroad. AcmeBiotechs helps our clients on preparing CFDA application, device. General Process of CFDA application. Create a free website. Create your own free website. Start your own free website.