Company Information
We strictly comply with the requirements of the medical device quality management system, establish a standardized record and traceability system throughout the entire process, and ensure full documentation and clear accountability for every link from demand alignment and technical R&D to production and delivery.
After we receive the sample-making request from a foreign customer, a joint review by multiple departments, including Sales, R&D, Production, and Quality, is conducted to verify the completeness of technical documents, process feasibility, quality controllability, and cost rationality.
The Quality Department exercises control throughout the entire production process, including incoming raw material inspection, in-process patrol inspection (with focused monitoring of critical processes), and finished product testing (which complies with customer requirements and industry standards).
| Company | EasyMed Scientific (易术致慧（深圳）医疗器械有限公司) |
| Specialty | Guidewire OEM Manufacturing for Cardiovascular & Interventional Medical Devices |
| Certification | ISO 13485 Certified |
| Location | Shenzhen, China |
| Contact | sales@easymedscientific.cn |
| Certification | Details |
|---|---|
| ISO 13485:2016 | Medical Devices — Quality Management System. Certified for design and manufacturing of cardiovascular guidewires and interventional medical devices. |
| CE Marking (MDR) | Medical devices compliant with EU Medical Device Regulation (MDR) 2017/745 requirements. |
| FDA Registration | Establishment registration and device listing with the U.S. Food and Drug Administration. |
| Cleanroom Facility | Class 100,000 (ISO 8) cleanroom manufacturing environment for medical device production and assembly. |