Elite Biomedical Consulting
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MEDICAL DEVICE REGULATION SERVICES

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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Site Links

Home
​Services
Contact
​

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@ivddreg.com
Site powered by Weebly. Managed by FreeLogoServices.com
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