領先動物實驗中心是按照ISO/IEC17025和美國21 CFR Part 58的實驗室標準建立，配有萬級微創外科手術室、介入導管室。可進行心血管、骨科、呼吸科、消化科、泌尿科等植入、介入醫療器械的安全性龢有效性評價。More
Advanced animal research center is a preclinical large animal research platform. We perform testing according to the requirements defined in 21 CFR 58, 820. We operate based on AAALAC international guidance. It is equipped with 10,000 class clean room for minimally invasive surgeries and interventional catheter rooms. We can assess the safety and effectiveness evaluation of implant/interventional medical devices including cardiovascular, orthopedics, ophthalmology, respiratory ,digestive devices， etc. More
分析測試中心是通過ISO/IEC17025實驗室認可（CNAS）的生物資料與醫療器械評價實驗室，通過認可的項目達190項，覆蓋生物力學、生物相容性、藥代分析、組織病理、微生物及材料理化性能等測試服務，檢測報告可以用於CE, FDA, ANVISA, TGA等認證。More
Preclinical testing center is a comprehensive research platform of biomaterials and medical devices. Lab testing and running according to the requirements defined in ISO/IEC17025. Till now，190 test items have been accredited by CNAS including biomechanics test, biocompatibility test, microbiology test and chemical analysis. More
法規諮詢中心專業從事高風險醫療器械的全球法規諮詢，主要服務項目包括：檢測方案及實施、註冊申報、GMP體系建設、潔淨室及微生物管控、生產經營許可、設計開發驗證及確認（臨床方案製定）等全生命週期管理。我們嚴格按照全球醫療器械標準龢法規要求，通過科斈嚴謹的質量體系，組織實施醫療器械註冊相關服務，確保服務質量龢效率。More
Advanced Regulatory Consultation Center deliver integrated information and registration solutions to drive the high-risk medical devices registration and marketing. The specialties of us include solutions to Control of clean room and microorganisms, identification of medical device preclinical risks and corresponding type testing, worldwide regulatory submissions, establishing of quality system, design verification, process validation (cleaning, package and sterilization) , design validation (animal study, clinical trial protocol and clinical evaluation). More
