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  • Training Course



    NO.

    Training Course

    Period (day)

    1

    ISO9001:2015 Quality Management Systems Requirements

    2

    2

    ISO13485:2016 Medical Devices--Quality Management SystemsRequirements

    2

    3

    FDA CFR PART 820 Quality System Regulations Training

    3

    4

    Training for Internal Auditor of Quality Management System

    3

    5

    Training on Establishment and Management of Clean Room (ISO14644)

    2

    6

    Training on Process Validation

    1

    7

    Training on Sterilization Validation, Process Monitoring and Package Validation

    3

    8

    Training on Chinese Regulations for Medical Devices

    3

    9

    EU 2017/745 Medical Device Regulation

    2

    10

    EU 2017/746 on in vitro diagnostic medical devices

    2

    11

    Training on Medical Device Regulations of Major Economies in the World

    2

    12

    ISO14971 Risk Management Training

    1

    13

    Training on Software Validation

    1

    14

    Training on Preparation of Technical Files for Medical Devices

    1

    15

    Training on Electrical Safety and EMC of Medical Devices (IEC60601)

    2