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Service Introduction

Training Plan

General standard for quality management

Medical device regulation training

-- 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

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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