Tech Medical Device Co., Ltd.
List of Management Programs

#	Code	Name of the Program	ISO13485 Item	Version
#	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

Tech Medical Device Co., Ltd.

Certification

Standard: SFDA

Number: #20192010280

Issue Date: 2019-04-01

Expiry Date: 2024-03-31

Scope/Range: TD1/TD2 Series

Issued By: SFDA

Standard: SFDA

Number: #20142010212

Issue Date: 2019-10-14

Expiry Date: 2024-10-13

Scope/Range: TD4 Series

Issued By: SFDA

Standard: SFDA

Number: #20142010206

Issue Date: 2019-07-19

Expiry Date: 2024-07-18

Scope/Range: Focepts for Hi-Frequency Generator

Issued By: SFDA

Standard: Patent

Number: 9707270

Issue Date: 2019-12-03

Expiry Date: 2029-12-02

Scope/Range: TD1 Series

Issued By: CNIPA

Standard: SFDA

Number: #20182020903

Issue Date: 2023-06-21

Expiry Date: 2028-10-22

Scope/Range: TQ Series

Issued By: SFDA

Standard: Patent

Number: 11660896

Issue Date: 2020-10-16

Expiry Date: 2030-10-15

Scope/Range: TD1 Series

Issued By: CNIPA

Standard: Patent

Number: 5133314

Issue Date: 2016-04-13

Expiry Date: 2026-04-12

Scope/Range: TD1 Series

Issued By: CNIPA

Standard: Patent

Number: 9703258

Issue Date: 2019-12-03

Expiry Date: 2029-12-02

Scope/Range: TD1 Series

Issued By: CNIPA

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