Medical Device Compatibility and Chemical Characterization

Based on the full scan and other material characterization data, conduct a appropriate risk assessment and qualitative/quantitative analytical method research and tests, with the latest analytical instruments such as LC-QTOF/LCMSMS/GCMSMS/ICP-MS for all kinds of leachables and extractabls in medical devices.

服务内容

●Medical Device Compatibility (Infusion delivery Sets/Indwelling Needles/Atomizers)

●Chemical characterization and identification of unknown objects.

●Known Leachable Substances Research.

●Unknown Leachable Substances Research.

服务流程

Q&A
 
Our Advantage
Authoritative qualification
NOA has been approved by Certification and Accreditation Administration of the People’s Republic of China(CNCA)(CNCA-R-2002-051), and has obtained qualification of China Inspection Body and Laboratory Mandatory Approval (CMA),and has passed the multiple approvals of China National Accreditation Service for Conformity Assessment (CNAS), International Accreditation Service (IAS), United Kingdom Accreditation Service (UKAS), Joint Accreditation System of Australia and New Zealand (JAS-ANZ). NOA has been approved by State Administration for Market Regulation of China, and has been recognized as inspection and testing institution of China's special equipment, as well as the qualification of China's national equipment supervision and engineering supervision. NOA-DCI is the notified body of the CE directive of the European Commission. NOA has been recognized by the International Electrotechnical Commission (IECQ) by obtaining Electronic Component Quality Assessment System. It is also a national inspection and assessment notified body of import and export commodity in China.NOA is a high-tech enterprise in Shanghai.
Improve Performance, Realize Asset Value Appreciation, and Service Throughout the Entire Value Chain
From pre-design to post-operation, NOA has the ability to guarantee the whole life cycle of the business. NOA, as an independent third-party inspection company, has a large number of domestic and international standards and specifications proficient in design, welding, non-destructive testing, painting, packaging and other fields The experienced team of professional engineers and inspection experts, with more than ten years of experience in the domestic market, is familiar with all aspects of the domestic industrial equipment supply chain, and can provide you with technical support services for the full life cycle of technical services in a timely manner, combining various products. Inspection, certification, testing, consulting, and auditing services can provide you with one-stop all-round comprehensive services.
Quality, Efficiency and Service
NOA has formed a mature and solid operation system in the development of more than 20 years. We let technical experts who are familiar with market regulations and testing standards and have professional industry experience to carry out inspection, evaluation and design review work. While meeting the requirements of domestic and international standards, we ensure that customers can obtain satisfactory service results in the first time with accurate time-sensitive management methods, and ensure that customers can seize the opportunity in the market competition.
Service Area
NOA inspection services currently cover Europe, Australia, Russia, some Middle East regions and most regions in China. NOA can ensure the consistency and continuity of customer service in different regions, and eliminate the impact of unfamiliar environments on customer quality. The guarantees and the impact of project implementation enable customers to participate in different markets across the country or around the world with flawless quality.

Tel:+86-400 821 5138

Fax:+86-21 3327 5843

Email:noa@noagroup.com

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