Service Introduction
NCE has set up a training center for the development of the medical device industry. Based in Beijing, NCE provides training services for the national medical device production and management enterprises. Provide skill training for medical device practitioners and management and skill training for medical device manufacturing enterprises. It helps employees and enterprises improve their competitiveness, creates more progress and promotion opportunities for the development of employees and companies, obtains the trust of regulatory authorities for enterprises, further escorts product safety, and makes due contributions to social medical and health care.
Training Plan
General standard for quality management --ISO 13485 and ISO 9001 internal auditor training (first forensics class, continuation of registration class) --ISO 14971 and ISO 24971 risk management training (Basic General course, Advanced Application Course) -- IEC 62366 Usability Engineering Training (General Education Course, Advanced Application Course) -- Standard training course YY/T 0664-2020 "Software Life Cycle Process of Medical Devices" -- Training class for management representatives
General standard for quality management
ISO 13485 and ISO 9001 internal auditor training (first forensics class, continuation of registration class) --ISO 14971 and ISO 24971 risk management training (Basic General course, Advanced Application Course) -- IEC 62366 Usability Engineering Training (General Education Course, Advanced Application Course) -- Standard training course YY/T 0664-2020 "Software Life Cycle Process of Medical Devices" -- Training class for management representatives
Medical device regulation training
General requirements of Good Manufacturing Practice of medical devices -- Appendix training: Sterile medical devices, implantable medical devices, in vitro diagnostic reagents, customized dentures, independent software -- Good Supply Practice of medical devices -- Regulations on the use and management of medical devices -- Special process confirmation and key process verification of medical device manufacturers -- Comprehensive analysis of flight inspection cases of production enterprises and training of system self-inspection ability improvement -- Medical device registration regulations and training of registration specialists -- Clinical evaluation of medical devices -- Training on unique identification of medical devices -- Medical device registration regulation -- Interpretation and discussion of the latest regulations (dynamic)
Medical device skill training
GB9706.1—2020 and electrical safety inspectors practical operation --New pharmacopoeia and Aseptic inspectors and aseptic laboratories practice operation
Medical device industry information sharing
Customize the course section -- Enterprise internal audit training class -- Enterprise Risk Management training Class -- Enterprise GMP, GSP special training course -- According to the needs of enterprises, the above courses can be combined to customize the training Companion training service - according to the needs of enterprises to provide long-term continuous services Public welfare training -- entrusted by the government and technical committee, held irregularly
Training instructors
Chen Jianjun, Zhang Bing, Milan Ying, Li Wencui, Liu Xia, Wang Mingfeng, Xue Hong, Chen Yanrui...
Necessity Certification (Beijing) Co., LTD.
NCE continues to track the development of international medical device certification, keeping pace with the world level of medical device certification, and has a wide range of exchanges and cooperation with medical device certification institutions around the world.
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