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
The in-house production system implements on-line monitoring, database management and analysis and enterprise resource planning (ERP) benefits, consisting of material, products, traceability of quality systems, and further improvements to the manufacturing process.
In-house production system
Every step of the manufacturing process is taken cautiously and with care, resulting in higher quality, better efficiency, and ultimately – better results.
Real-time information feedback system: The online management information system allows for the monitoring of quality levels in the production process. The computerised parameter control works closely with the quality system and thus ensures uncompromising consistency and accuracy in every single strip.
Database analysis & management system: Production data and parameters are collected and then analyzed by the Database Analysis & Management System in order to record production standardization and product traceability.
Vertical & Horizontal Systematic Integration
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. Further more, IECQ 080000 has been implemented to the manufacturing process since 2008 to comply with green regulations.
Certificates and Product Capacity
- Production and assembly lines of medical device
- Gold electrode strip manufacturing facilities
- Strip packaging facilities
- Carbon electrode strip manufacturing facilities
- Automated strip canning and packing equipment
Quality System Certificates
- ISO 9001: 2015
- ISO 13485: 2016
- GMP: 2003
- QSR Compliance
- Medical Device Directive 93/42/EEC
- In Vitro Diagnostic Medical Device Directive 98/79/EEC