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Quality Comes From Caring
Caring for our products, customers, employees, suppliers, and the environment is our shared mission. Through this mission, we are dedicated to providing world class quality products and services.
We are constantly adapting to the evolution of international medical device regulations. Utilizing Risk Management, 6 Sigma, and Total Quality Management tools, we've developed a verification and validation process that both adheres to international regulatory standards and meets our customers' needs.
From product conceptualization and development, verification & validation, to mass production and market feedback, our product development process is tightly interwoven with our Total Quality Management System, allowing us to provide high quality products and services as a total solution provider to our customers.
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- FDA Register
- TFDA Permit of Taiwan Pharmaceutical Manufacturer License
- ISO13485 Quality Management System Certified
- CE Mark
- Taiwan GMP Certification
- ISO17025 TAF (Taiwan Accreditation Foundation) Micro-bio Lab Certification
- KGMP Certificate of GMP
- JGMP Japan BG 10600125 Registration Certificate of Foreign Medical Device Manufacturer
- GSV Global Security Verification
- ISO14001 Environmental Management Systems Certified
- MDSAP (Medical Device Single Audit Program) Certified
- ISO45001 Occupational Health and Safety Management Systems Certified
- EU MDD The European Union Medical Device Directive
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