Our Services

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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)