Company Information
The members of the founding team all come from well-known domestic and international medical device enterprises. We have rich experience and outstanding standards in the fields of design, development, production management & quality management. We are particularly proficient in the full-life-cycle risk control of high-risk and high-value-added medical products.
They have over 10 Years Experience in customization, and strong Customization Capability .Team members are from leading domestic and international enterprises such as St. Jude Medical, Inc., B.Braun, and Bain Medical. They all have rich experience in design, development, process and technology fields.
We have established cooperative relations with Shenzhen Technology University & Tianjin Medical University Cancer Institute and Hospital.We focus on research topics such as new material development, new technology transformation, animal experiments, medical-engineering transformation, and clinical trials, so as to promote technology implementation and achievement transformation.
| 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. |