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Quality
which specializes in R&D, manufacture and marketing of disposable medical products.
Quality
DSB Medical has passed ISO 13485 certification, CE certification and FDA 510(k) certification, and complies with EU MDR regulations.
Reducing the risk of hospital-acquired infections (HAIs) is essential to patient safety in today’s healthcare environment. At DSB, we adhere to high standards and maintain rigorous controls to ensure product integrity from manufacture through to procedural use. The key standards we adhere to include:
- FDA CFR 21 Part 820 — Quality System Regulation
- ISO 13485 — Medical devices — Quality management systems
- ISO 14644 — Cleanrooms and associated controlled environments
- ISO 11607 — Packaging for terminally sterilized medical devices (Parts 1 & 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 right balance of cost and compliance.
Our Quality 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.
Throughout production, inspection and distribution, we always put quality first; we comply with relevant regulatory requirements, meet customer requirements, and fully understand and develop customers’ potential and future needs to achieve mutual growth.
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 |
If you have more needs?
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355 Longjin Road, Changzhou Economic Development Zone, Jiangsu Province, China
DSB Medical – FDA & CE Approved Disposable Medical Supplies Manufacturer for Europe & USA. Privacy Policy | SEO