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.

Customer oriented

To achieve continuous product improvement

Quality takes precedence over profit

Company 5s management

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.)

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

Tensile test machine

Mechanical performance tests such as stretching, stretching, compression, bending, cutting, and peeling of products and accessories can be performed

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