ITES China Shenzhen International Industrial Manufacturing Technology and Equipment Exhibition

Company Introduce

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.

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