Our company are managed by GMP system (ISO 13485), the following are the main management programs in place :
| Tech Medical Device Co., Ltd. |
| List of Management Programs |
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| # |
Code |
Name of the Program |
ISO13485 Item |
Version |
| 1 |
TP-04-01 |
Program for Documents System |
4.2.3 |
A/2 |
| 2 |
TP-04-02 |
Quality Control and Record Management |
4.2.4 |
A/2 |
| 3 |
TP-04-03 |
Program of Management Duty |
4.2.5 |
A/2 |
| 4 |
TP-05-01 |
Program for Management Assessment |
5.6 |
A/2 |
| 5 |
TP-06-01 |
Cability and Awareness and Training |
6.2.2 |
A/2 |
| 6 |
TP-06-02 |
Production Enviroment Control |
6.3+6.4 |
A/2 |
| 7 |
TP-07-01 |
Customer Demand Management |
7.2 |
A/2 |
| 8 |
TP-07-02 |
Design and Development Management |
7.3 |
A/2 |
| 9 |
TP-07-03 |
Purchasing Management Program |
7.4 |
A/2 |
| 10 |
TP-07-04 |
Production management Program |
7.5.1 |
A/2 |
| 11 |
TP-07-05 |
Label and Retracable Management |
7.5.3 |
A/2 |
| 12 |
TP-07-06 |
Store and Shipment Protection Management |
7.5.5 |
A/2 |
| 13 |
TP-07-07 |
Serivce and Return of Goods Program |
7.5.1 |
A/2 |
| 14 |
TP-07-08 |
Facility and Testing Devices Management |
7.6 |
A/2 |
| 15 |
TP-07-09 |
Product Risk Management Program |
7.1 |
A/2 |
| 16 |
TP-07-10 |
QC and Testing Control Program |
7.5.3 |
A/2 |
| 17 |
TP-07-11 |
Sterilization Validation Control Program |
7.5.2.2 |
A/2 |
| 18 |
TP-07-12 |
Warehouse Management Program |
7.5.5 |
A/2 |
| 19 |
TP-08-01 |
Customer Feedback and Satisfaction Mgmt |
8.2.1 |
A/2 |
| 20 |
TP-08-02 |
Quality System Internal Assessment |
8.2.2 |
A/2 |
| 21 |
TP-08-03 |
Product Monitoring and Measurement |
8.2.4 |
A/2 |
| 22 |
TP-08-04 |
Management for Disqualified Products |
8.3 |
A/2 |
| 23 |
TP-08-05 |
Data Analisis Management |
8.4 |
A/2 |
| 24 |
TP-08-06 |
Improvement and Corrrection Management |
8.5 |
A/2 |
| 25 |
TP-08-07 |
Adverse Event and Notice Control |
8.5.1 |
A/2 |
| 26 |
TP-08-08 |
Early Fault Alarm Management |
8.2.1 |
A/2 |
| 27 |
TP-08-09 |
Investgation of Customer Complaining |
8.2.1 |
A/2 |
| 28 |
TP-08-10 |
Validation Management |
7.5.2.2 |
A/2 |
| 29 |
TP-08-11 |
Contract Evaluation Process |
8.2.1 |
A/2 |
Our testing instruments can be grouped into 2 kinds: Electrical Testing Instruments, Biological Testing Instruments. The following pictures are only a part of our testing instruments.
The Electrical Testing Instruments (showed) include:
1) Hi-Frequency Generator;
2) 9000V High votage Testing machine.
3) Electric Currency Testing Device
The Biological Testing Instruments (showed) include:
1) Microscope
2) Micro-dust Testing Instrument.
3) Ultraviolet Spectrophotometer
4) 10k degree testing room
5) 100 degree biological Safety Cabin
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