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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)