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AcmeBiotechs Consulting Incorporation
Questions? Call +886-2-2258-9658

Our Services


Certification Related Services:
  • Regulatory Consulting
  • Quality System Counseling
  • Device Registration
United State Food and Drug Administration (U.S. FDA)
  • Establishment Registration and Device Listing
  • U.S. Agents
  • Premarket Notification, 510(k)
  • Investigational Device Exemption, IDE
  • Premarket Approval, PMA
  • QSR Inspection
European Union CE Marking
  • ISO 13485:2003
  • CE marking certification, MDD Technical Construction File
  • Clinical Evaluation
  • EU Risk management Report
  • European Authorized Representative
Taiwan Food and Drug Administration (TFDA)
  • Device Registration   
  • Taiwan Quality System Documents (QSD)
  • Taiwan Product License
Examination Services:
  • Sterilization Validation
  • Preclinical Studies
  • Clinical Strategy Review
Biocompatibility
  • Cytotoxicity, ISO10993-5
  • Skin Irritation in Rabbit, ISO10993-10
  • Eye Irritation in Rabbit, ISO10993-10
  • Intracutaneous Irritation in Rabbit-with 2 extracts, ISO10993-10
  • Pyrogen Test in Rabbit, USP/ISO10993-11
  • Acute Systemic toxicity in Mice – with 2 extracts, ISO 10993-11
  • Skin Sensitzation Test in Guinea Pig(Maximization Method) with 2 extracts- ISO10993-11
  • 12-weeks Bone Implantation with histopathology in Rabbit -ISO10993-6
  • Hemolysis- ISO10993-4 
  • 14-days Subacute Systemic toxicity(IV) in Mice -ISO10993
  • Subchronic Intravenous toxicity 28 days-ISO 10993-11
  • Subchronic Intravenous toxicity 90 days-ISO 10993-11
  • Mucous membrane Irritation
Electrical Device Safety and Electromagnetic Compatibility
  • Medical electrical device Safety
  • Electromagnetic Compatibility (EMC)
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