Company Profile

Guangzhou MedClear Medical Device Service Co., Ltd. was established in 2017 and is dedicated to providing professional technical services and one-stop solutions to clients in the medical device industry and related fields. The services offered include Ethylene Oxide(EO) sterilization services, regulatory & QMS consulting services, and testing services. EO sterilization services primarily provide  professional  Ethylene Oxide (EO) sterilization process development, sterilization validation, and routine sterilization services for medical devices, pharmaceutical packaging, cosmetics, and other sanitary products. Regulatory & QMS consulting services mainly assist domestic and international medical device companies with product registration, establishment and improvement of quality management systems, training and introduction of medical device regulatory standards, submissions for innovative medical devices, and design of cleanrooms and laboratories. Testing services provide microbiological test, ethylene oxide residue test, cleanrooms test, and sterile barrier system test for medical devices, pharmaceutical packaging, and other related industries.

We place high importance on the construction of quality management systems and professional technical capabilities. Since its inception, it has obtained ISO 13485 and  ISO 11135 certificate issued by TÜV SÜD, CNAS certificate issued by the China National Accreditation Service for Conformity Assessment and the CMA certificate issued by Guangdong Administration for Market Regulation. The company has also completed registrations with U.S. FDA and Japan's PMDA.

We adheres to the founding principle of 'Profession to Create Value', with safety and compliance as the foundation of our operations. We are committed to continuously enhancing our professional capabilities and strive for constant improvement.  By offering customized solutions and professional technical services that exceed customer expectations, our company aims to co-create value and contribute to the development of the industry.

Fully Qualified
Fully Qualified
ISO 13485 certificate, ISO 11135 certificate, U.S. FDA registration, Japan PMDA registration, ISO/IEC17025:2017 CNAS accreditation certificate, CMA qualification certificate.
Professional Team
Professional Team
Our core team members bring over 15 years of profound expertise in sterilization and package, testing, regulatory and registration affairs, and quality management systems within medical device industry.
Advanced Equipment
Advanced Equipment
We offer eight sterilization chambers of varying sizes to meet the diverse needs of our clients. Small size sterilizer is equipped with a cooling system to support low-temperature sterilization processes.
One-Stop Service
One-Stop Service
We provide one-stop services for sterilization validation and processing, testing, and quality regulatory consulting. Our professional, integrated solutions support medical devices throughout their entire lifecycle.

Corporate Culture

企业文化
Vision

Vision

Dedicate to becoming an influential company in the field of Ethylene Oxide (EO) sterilization services, global medical device quality regulatory consulting, and testing services.
Values

Values

Customer First, Integrity and Cooperation. Professional and Efficient,
Outstanding Growth.
Mission

Mission

Provide customers with Ethylene Oxide (EO) sterilization services, medical device quality regulatory consulting, and testing services, to exceed customer expectations with customized solutions and professional technical services.

Development History

2023

Dongguan Sterilization Factory established

EN ISO13485:2016 and EN ISO11135:2014 certified

2023

2022

Guangzhou MedClear Medical Device Testing Service Co., Ltd. established

CNAS certified

2022

2021

The second phase expansion of Guangzhou Sterilization Factory completed, and the sterilization capacity increase

2021

2020

FDA registered

CMA certified

2020

2019

Guangzhou Sterilization Factory established

ENISO13485:2016 and EN ISO11135:2014 certified

2019

2017

Guang Zhou MedClear Medical Device Service Co., Ltd. established

2017