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醫療器材認證服務項目
Medical Device Certification Services
Agency Services for Medical Device Import QSD/Licenses
A. New Medical Devices (Class I, II, III)
B. General Medical Devices (Class I, II, III)
C. Transfer, modification, or renewal of medical device licenses
D. Explanation of the "Streamlined Mode" for QMS/QSD Applications
E. 其他（測試標準咨詢、醫療器材廣告申請等）
E. Other (Consultation on testing standards, medical device advertising applications, etc.)
ISO 13485 Quality System Certification Consulting
A. Consulting for QMS and ISO 13485 Quality System Assessment and Implementation
Consulting and guidance on medical device software validation and verification
A. QSD (Application, Extension, Amendment, etc.)
Agent in Taiwan for foreign medical devices
我們為客戶提供醫療器材行業全方位服務，如您是國外的醫療器材商，歡迎詢問，我們擁有可靠且靈活的諮詢方法及服務，能夠滿足您特定需求的客制化服務。
We provide comprehensive services for the medical device industry. If you are an overseas medical device company, we invite you to contact us; we offer reliable, flexible consulting and services, including customized solutions tailored to your specific needs.
Consulting for Good Distribution Practice (GDP) Certification
為確保藥品、醫療器材在儲存與運輸過程中維持其品質及完整性，GDP強化醫材供應鏈管理，防止不良醫材進入合法供應鏈。
To ensure the quality and integrity of pharmaceuticals and medical devices during storage and transportation, GDP strengthens supply chain management for medical devices and prevents substandard products from entering the legitimate supply chain.
美國醫療器材產品註冊列名（510(K) application）
U.S. Medical Device Registration and Listing (510(k) Application)
申請人或公司必須將欲申請上市的醫療器材與已在美國FDA上市之一種或多種相似產品做比對，證明其具實質相等性。
The applicant or company must compare the medical device intended for market clearance with one or more similar products already marketed in the U.S. and approved by the FDA, in order to demonstrate substantial equivalence.
EU MDR Quality System Consulting
Authorized Representative)，確保產品
The EU requires manufacturers based outside the EU to designate an EU Authorized Representative within the EU to ensure the safety and efficacy of products entering the EU market.