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Yjton Consulting: China's Leading Medical Device CRO and Regulatory Consultancy
Yjton Consulting is a leading medical device Contract Research Organization (CRO) in China, providing innovative solutions for clinical research and regulatory compliance. With a team of experienced professionals, Yjton Consulting has established itself as the largest medical device regulatory consultancy in China.
Founded in 2008, Yjton Consulting has been at the forefront of the medical device industry in China. The company offers a wide range of services to its clients, including clinical trial management, regulatory affairs consulting, quality management system (QMS) development and implementation, post-market surveillance (PMS), and more.
One of the key strengths of Yjton Consulting is its expertise in navigating the complex regulatory landscape for medical devices in China. The company's team of experts has an in-depth understanding of Chinese regulations and can provide tailored solutions to meet clients' specific needs. Whether it's obtaining product registration or conducting clinical trials, Yjton Consulting can help companies navigate through all stages of the process.
In addition to its regulatory expertise, Yjton Consulting also offers comprehensive clinical trial management services. From study design to site selection to data analysis and reporting, Yjton Consulting provides end-to-end support for clinical trials across various therapeutic areas.
Yjton Consulting also places great emphasis on quality management systems (QMS). The company helps clients develop QMS that comply with international standards such as ISO 13485:2016 and FDA QSR requirements. By implementing robust QMS processes, companies can ensure that their products meet high-quality standards throughout their lifecycle.
Another area where Yjton Consulting excels is post-market surveillance (PMS). The company helps clients monitor their products' safety performance after they have been launched into the market. By collecting data on adverse events or complaints related to products' use or performance issues from customers or healthcare providers through PMS, Yjton Consulting can help companies identify potential issues and take corrective actions to ensure patient safety.
Yjton Consulting's commitment to quality and compliance has earned it a reputation as a trusted partner for medical device companies in China. The company has worked with numerous clients, including multinational corporations, local manufacturers, and start-ups. Its client base spans across various therapeutic areas such as cardiovascular, orthopedics, neurology, ophthalmology, and more.
In conclusion, Yjton Consulting is China's leading medical device CRO and regulatory consultancy that provides innovative solutions for clinical research and regulatory compliance. With its expertise in navigating the complex regulatory landscape in China and its comprehensive services ranging from clinical trial management to post-market surveillance (PMS), Yjton Consulting is well-positioned to help companies bring their products to market efficiently while ensuring patient safety.
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