Our Range of Regulatory and IVD Product Development Consulting Services

MEDICAL DEVICE AND IVD DEVICE LICENSING / 醫療器材產品相關證照輔導

• FDA – 510(k) (Class I and II)
• FDA CLIA Waiver Application
• Health Canada Medical Device License (Class I, II, and III) / 加拿大衛生部醫療器材證照​

• tFDA
• European Union Medical Device Regulation (MDR)
• European Union In Vitro Diagnostic Regulation (IVDR)

QUALITY SYSTEM COMPLIANCE / 品質系統 (教育訓練,查廠/稽核協助, 認證輔導)

• US FDA – Quality System Regulations Compliance
• Medical Device Single Audit Program (MDSAP)
• ISO 13485​

MEDICAL DEVICE SOFTWARE / 醫療器材相關軟體輔導

• Software Technical Document (Review or Development)
• Software Verification and Validation
• Cybersecurity Document (Review and Development)

IN VITRO DIAGNOSTICS DEVICE STUDY / 臨床診斷試劑適用性評估

• Feasibility Study (USA or Taiwan)
• FDA CLIA Waiver Clinical Study (USA or Taiwan)

US FDA REGISTRATION AND DEVICE LISTING / 美國食品藥物管理局註冊與代表*

• ​Online Account Registration and Maintenance (OAA)
• US Agent*
• Electronic Medical Device Reporting (eMDR)*
• *With Our US Partner

THIRD PARTY AUDITING SERVICE / 第三方稽核 (協助供應商或投資審查稽核)

• Regulatory and Quality System Audit

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Elite BioMedical Consulting, Inc.

233 Fuxing 2nd Rd., 5F, Suite 5
Zhubei City, Hsinchu County 30271, Taiwan

U.S. Branch
29122 Rancho Viejo Rd., Suite 212
San Juan Capistrano, CA 92675
​

Contact Information

Phone: 03-6576763
Email: info@elitebioconsulting.com

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