Necessity Certification (Beijing) Co., LTD. (Company brand identity: NCE) is committed to providing Chinese customers with specialized, professional and differentiated integrated solutions that based on ISO13485 standard and Compliance with Chinese regulations, including management system audit, certification and training services, as well as product testing services which integrated with Chinese regulations.
　　NCE entrepreneurs have been working in medical device manufacturing companies and certification services for many years. We understand how employees work, the habits they form, and how they achieve improvement. Founded an NCE due to market demand, We have experience in the management of medical device enterprises. The most important is to have certification, technical services for many years of business executives and auditors in the medical industry for many years we know the domestic and international medical equipment product related regulatory requirements, and regulations into the enterprise quality management system in the process of service, Enable enterprises to confidently accept the industry regulatory and market challenges. These people are our best combination, and continue to learn and train them so that they can train and support you, perfect post-certification services, to help you make the pursuit of excellence become your organization's conscious behavior, we achieve win-win.
　　With the development and progress of science and technology, the improvement of people's living standards, and the demand for medical health, it means that the quality of medical products is increasingly high, almost the pursuit of perfection. New regulations and standards are updated more and more frequently. Regulatory authorities have increasingly stringent risk requirements for medical devices. NCE has several medical device professionals and through continuous learning and working practice, we are always leading in the field of regulation and standards. If certified by NCE, it will give you confidence to customers, competitors, suppliers, employees and investors. The company meets the requirements of regulations, standards, and industry best practices of new technologies, and demonstrates the capabilities and growth potential of enterprise design and development.
　　The company's professional auditor comes from the authoritative and experienced certification bodies in the industry, with the most professional full-time auditor and lecturer team than other certification bodies. We have built three operation centers in China, distributed in Beijing, Shanghai and Shenzhen, with staff all over the provincial capital cities, which can meet the quality system operation evaluation and certification of medical device manufacturers in various provinces and cities across the country. You can get the most benefit from evaluation and certification by maximizing cost savings for your business.
　　Once you have obtained the certification, our after-sales service personnel will be the relevant domestic medical device regulations, standards and other information timely through the network tool to you, prompting enterprises to pay attention to and implement. We will visit you regularly on site to review whether your company continues to meet the requirements of laws and regulations and standards, and fulfill the requirements of regulations and standards according to the planning of normative documents and records, and promote the effective operation of enterprise quality system. We will carefully select auditors with relevant industry experience tailored to your company's specific product and company specific needs to ensure that their extensive knowledge and experience add value to the enterprise's services, experience evaluation and certification.