Quality

Passed ISO 13485 certification, CE certification, FDA 510K certification, and complies with 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.

During the process of production, inspection and the distribution, we always put Quality on the primary position; obey the relative regulatory requirement, meet the customer requirement; fully understand and develop the potential and future requirement of the customer to achieve mutual development.

Customer oriented

To achieve continuous product improvement

Quality takes precedence over profit

Company 5s management

Quality Six Sigma Management

Product name	Product registration number
Negative pressure drain	苏常械备20170128号
Negative pressure drainage device (curing type)	苏常械备20190332号
Urine collection bag	苏常械备20190236号
Portable urine collection bag	苏常械备20190235号
Powder inhaler	苏常械备20220074
Medical surgical mask	苏械注准 20212140679
Disposable medical mask	苏械注准 20212140695