Certificates
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Standard: SFDANumber: #20192010280Issue Date: 2019-04-01Expiry Date: 2024-03-31 -
Standard: SFDANumber: #20142010212Issue Date: 2019-10-14Expiry Date: 2024-10-13 -
Standard: SFDANumber: #20142010206Issue Date: 2019-07-19Expiry Date: 2024-07-18 -
Standard: SFDANumber: #20182020903Issue Date: 2023-06-21Expiry Date: 2028-10-22 -
Standard: PatentNumber: 9707270Issue Date: 2019-12-03Expiry Date: 2029-12-02 -
Standard: PatentNumber: 11660896Issue Date: 2020-10-16Expiry Date: 2030-10-15 -
Standard: PatentNumber: 5133314Issue Date: 2016-04-13Expiry Date: 2026-04-12 -
Standard: PatentNumber: 9703258Issue Date: 2019-12-03Expiry Date: 2029-12-02
QC Profile
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 | ||||
| # | 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
