Quality assurance tests are conducted on circuit board calibration, mechanical assemblies, unit comprehension and related processes. For assuring reliable quality of all medical devices produced, all production facilities are based in Taiwan.
Advanced Manufacturing Facilities & Well-Trained Human Recourses
- Manufacturing facilities and an environment that surpasses national standards (GMP)
- Well-trained and experienced production force
- Efficient and accurate design flow
- Integration of mechanical designing and mold fabrication
- Integration of the electronic design and SMD process
- Development of testing instruments & devices for production automation
- PCBA Calibration
- Functional evaluation
- Communication test
TaiDoc adapts rapidly to any OEM/ODM demands and with its flexible production and implementation of ERP and conformation to GMP, ISO 9001, ISO 13485 and IEEE, TaiDoc has made it possible for efficient diversification to take place. Furthermore, IECQ 080000 has been implemented to the manufacturing process since 2008 to comply with green regulations.
Quality Assurance Procedures
- Total quality management, TQM
- On-going reliability test, ORT
- Manufacturing verification testing, MVT
- Quality verification testing, QVT
- Continuous improvement program CIT
- Supplier quality management SQM
World-Class Quality Assurance
Being a quality oriented company, TaiDoc offers a best-in-class, worldwide medical device quality management system that enables the company to meet stringent quality and process controls.
TaiDoc's Quality System Control Center was established in 2003, which is combined by 5 different sections: Document Control Center, Auditing Section, Medical System Section, Complaint Handling Unit, and Return Merchandise Authorization.
TaiDoc’s Quality System Certificates
- ISO 9001: 2008
- ISO 13485: 2003
- QSR Compliance
- Medical Device Directive 93/42/EEC
- In Vitro Diagnostic Medical Device Directive 98/79/EEC