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Objective-focused CDMO partner in the development and delivery of innovative solutions to enhance user experience

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Perfect Quality System

Quality management system:

passed ISO 13485 certification, CE certification and FDA 510K certification, meeting the requirements of MDR regulations.

Reducing the risk of hospital acquired infections (HAI’s) is essential to patient safety in today’s health care environment. At DSB, we adhere to high standards and maintain rigorous controls to ensure product integrity from manufacture through to the time of procedural use. Here are some of the key standards that we adhere to:

● FDA CFR 21 Section 820 Quality System-Regulation

● ISO 13485 Medical Devices Quality System Requirements

● ISO 14644 Clean room and associated controlled environments

● ISO 11607- Packaging for Terminally Sterilized Medical Devices Parts1&2;

● ISO-11135- Sterilization of Healthcare Products- Ethylene Oxide

● ISO 10993-7- Biological evaluation of medical devices

Whether your need is an individual product or a series of components packaged as a kit, DSB can work with you to achieve the delicate balance of cost and compliance.

Goal

DSB Medical is committed to manufacturing medical products that meet customer requirements and the legal and regulatory requirements of the customer's target market. The cornerstone of our quality management system is to build quality into our products, processes and commitment to continuous improvement.

1. Customer-centric
2. To achieve continuous product improvement
3. Quality takes precedence over profit
4. Company 5s management
5. Quality Six Sigma Management

Customized Development&CDMO

Thanks to our long-term cooperation with customers in many different projects, we can flexibly design customized services

Performance:

● Customizing test methods
● Cooperation on R&D projects for testing (method implementation report)
● Regulatory affairs (such as declaration support)
● Quality: quality assurance and quality control (development of test methods for incoming and quality assurance release; mutual calibration - comparability study)
● R&D (development of test methods for new products)
● Training (specifications, regulations, test procedures, etc.)

Technologies & Manufacturing Equipment

Mold Development

Has several high-precision CNC machine tools imported from Japan, focusing on the development of multi-cavity medical equipment molds

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Automation Development

A number of fully automated production lines with independent research and development and intellectual property rights

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Equipment/ Processing Capability

Has the industry's high-end special film, precision plastic parts production equipment and production process

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Packaging Capablility

100,000-level purification workshop intelligent packaging production line with customized solutions

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lnspection and Analytical Capability

Liquid chromatography

Detects the specific content of deposited drugs at all levels after simulating the human body inhaled drugs

Gas Chromatograph

EO residue after detecting the product sterilized

Nikon projector

The three -hole rotating lens rack, precision linear rail workbench, 1um electronic ruler read, precision 0.01un, used for high -precision product imaging detection

Biological safety cabinet

Bio-safety cabinets (biological safety cabinets. BSC) is the most basic safety protection equipment in the first level of protection barrier in the laboratory biosafety, applied to microbiology, biomedicine, genetic engineering, biological products and other fields of scientific research, testing and production.

Biochemical incubator

Biochemical incubator is used in low-temperature constant-temperature test, culture test, environmental test, etc.

Tightness Tester

Compatible with OSHA, national standards and other standards, and can be customized test standards.

Synthetic Blood Penetration Tester for Masks

It is used to determine the resistance of medical protective masks to the penetration of synthetic blood under different test pressures.

Pretreatment test chamber (aging test chamber)

Applicable to product safety performance testing to provide reliability experiments, product screening experiments, etc., and at the same time, through the experiment, to improve the reliability of the product and the quality control of the product. Test samples in the high and low temperature and humidity test temperature environment after rapid changes in performance changes

Dust particle counter

Sample and analyze airborne dust particles for measurement.

Comprehensive Performance Tester for Luer Joints

Used to measure a number of performance indicators such as liquid leakage, air leakage, separation force, unscrewing torque, ease of assembly, anti-slip wire resistance, stress cracking, etc. of conical fittings (locking and non-locking) for syringes, hypodermic needles, infusion sets, blood transfusion sets, infusion needles, catheters, anesthesia filters, and other medical devices (luer).

Sprint iQ

This device is capable of providing multiple testing techniques in one machine, including leak, flow, burst, and occlusion testing.

Three- coordinate measuring system

Measure three -dimensional stereo workpiece, measure high -precision geometric parts and curved surfaces, mechanical parts with complex shapes, free curved surfaces, optional contact or non -contact measuring heads for continuous scanning

ACI impactor

Drug deposition of the human body inhalation preparation when inhaled throat, lungs and other parts

Gas circulation tester

Can be seal test experiments on the product

VMS image measuring instrument

The geometric size of the product, including diameter, radius, length, angle, width, height, depth, point distance, distance from point -to -line point, distance from the point, round heart distance, and so on.
Applying for precision injection molding requirements, testing of precision multi -cavity plastic parts