Medical Device Service
One-stop Medical Device Development Service
01.
medical device knowledge promotion talent training
02.
medical device quality system construction aonsulting
03.
medical device testing and verification
04.
medical device design and development
Safety Evaluation of Medical Devices
Focus on the polymer field
1
Medical Devices-
Final products, semi-manufactures, and raw materials.
2
Biocompatibility Tests-
ISO 10993, USP 88, OECD, CNS
3
Perormance & Susceptibility Tests
4
Package Integrity Tests-
ISO, EN, ASTM
5
Extractable & Leachables Tests- Pharmacopeia, ISO
6
Microbiological Tests Sterilization Validation Service
Biomedical Department
R & D • Test & Verification • System Verification
Biomedical Technology
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Medical device study, design & processing
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Design and Analysis (PP, PVC, TPU, Silicone….)
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Surface modification technology
Medical Device
Test & Verification
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Pre-Clinical Product Testing Requirement
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Biocompatibility Test
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Package Integrity & Sterilization Validation Test/Full Report
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Pharmaceutical Chemical Migration Test
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Microbe Test
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Product Functional & Product Durability Test
Medical Device-ISO 13485 and QMS quality system construction consulting
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ISO 13485 quality system construction consulting
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QMS Certification service
Taiwan TFDA Medical Device Registration
TFDA Medical Devices Consultant to register QSD and products permit licenses. Prepare required documents and after-application follow-ups.
We can provide you the professional and value-added assistance whether an existing medical device category or an innovative, high-risk medical device. From determining the application pathway to researching and documentary preparing our team can help, making you fully understand the regulations of medical devices, so that your product can be certified lightning-fast and then put on the market.
Diagnosis of the Technical Documents
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Risk Management Report (ISO 14971)
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Human Factors Engineering Report (IEC 62366-1)
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Clinical Evaluation Report