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Service Introduction

Training Plan

General standard for quality management

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)

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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