Capability-Hangzhou SKS Health Technology Co., Ltd

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CORE COMPETENCIES

SKS Health focuses on innovative research and development in the field of medical devices and life sciences, and provides a full range of medical product solutions worldwide

R & D capabilities

Innovative interdisciplinary research and development, with technology covering software and hardware design; Customize Soc ISP chips and CMOS modules; Multi spectral applications, computer-aided diagnosis (CADX); Camera module design, mechanism design, material application research; Process design, optical application design, and innovative appearance design.

Production capacity

A reliable production solution, providing integrated services from testing and validation, small-scale testing to mass production. The mass production site complies with the requirements of the Drug Administration's GMP regulations, quality system certification, and production license; Production process optimization complies with regulations and ISO13485 system certification and production license to ensure product quality and safety.

Quality system

Complete design documents (DHF \ DMR) that meet traceability requirements; A sound quality management system that meets the production requirements of sterile active instruments and ensures the quality of product production; Support product registration inspection and provide assistance services; Provide quality management system consulting services.

Provide consultation on medical regulations and collaborate on product registration; Write a complete set of technical documents for design and development for clients; Assist clients in establishing a sterile quality management system and providing comprehensive sterile validation services.

MANUFACTURE

Our production facilities are equipped with cleanrooms of Class 1000, Class 10000, and Class 100000.

We have obtained ISO 13485 and QSR 820 certifications.

A group of highly skilled researchers who are precise in their work and meticulous in their attention to detail.

Improve medical services through innovative technologies to protect every life

Tel: +086 133-3618-9791
Email: sks@skshealth.com

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NEED HELP?

Any questions can give us a message, we have professional staff to reply to you, please be sure to fill in the correct contact information!

Tel: 86133-3618-9791 Email: sks@skshealth.com