Guangzhou MedClear Medical Device Service Co., Ltd.

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Our Services

01.

EO Sterilization Services

Our company primarily provides Ethylene Oxide (EO) sterilization process development, sterilization validation, and routine sterilization services to industries including medical devices, pharmaceutical packaging, cosmetics, and other sanitary products.

02.

Testing Services

We primarily offer testing services for industries such as medical devices, pharmaceutical packaging, cosmetics, and other sanitary products.The test items include microbiological test, ethylene oxide residue test, cleanrooms test, and sterile barrier system test, etc.

03.

Regulatory & QMS Consulting Services

We primarily provide quality regulation consulting services to domestic and international medical device companies. These services encompass product registration in major global markets (including NMPA, CE, FDA, etc.), establishment and improvement of quality management systems (including GMP, ISO13485, QSR820, etc.), training and introduction of medical device regulatory standards, submissions for innovative medical devices, and design of cleanrooms and laboratories.

About MedClear

Guangzhou MedClear Medical Device Service Co., Ltd. was established in 2017 and is dedicated to providing technical services and 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.

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

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

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

Product Lifecycle Services

We provide services for sterilization validation and processing, testing, and quality regulatory consulting. Our professional, integrated solutions support medical devices throughout their entire lifecycle

Quality Assurance and Qualification

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.