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TRAINING CENTER

ICMC (International Certification Management Center Co., Ltd.)

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icmcert@naver.com

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+82-2-851-3111


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ICMC Training Center
+82-2-6226-9775

Medical Device RA Training

In Vitro Diagnostic/Medical Device RA Training


Training Program Introduction

This course develops overall knowledge about the 'legal and scientific regulatory standards' necessary for the medical device industry, such as product development, domestic and foreign certification and licensing, production and quality control based on a basic understanding of in vitro diagnostics/medical device RA. This is also a course to strengthen the competency of company personnel through practical training.
we train experts in quality management systems and regulatory affairs identifying the legal regulatory standards of in vitro diagnostic/medical device sales countries and proving the safety and effectiveness of medical devices.




Training Program Purpose

1
Understanding the in vitro diagnostic/medical device industry and regulatory standards
2
Acquisition of regulatory affairs related knowledge
3
Training talented individuals with expertise in in vitro diagnostic /medical device RA



Recommended To Whom

1
Medical device companies wishing to provide in vitro diagnostic /medical device RA training
2
In vitro diagnostic /medical device field worker
3
Those who wish to acquire RA expert certification
4
Those who wish to work as an international auditor or GMP auditor in the in vitro diagnostic /medical device field



Curriculum

Category Main content Details
Training Course
In vitro diagnostic/ medical device RA definition
- Definition and scope of in vitro diagnostic/ medical device RA
RA(Regulatory Affairs)
- Understanding the in vitro diagnostic/ medical device industry and RA processes
- In vitro diagnostic/ medical device standards and tests
In vitro diagnostic/ medical device clinical test and GCP
- Understanding of in vitro diagnostic/ medical device clinical test regulations
In vitro diagnostic/ medical device quality control (GMP)
- Understanding of in vitro diagnostic/ medical device quality and quality control (GMP)
- In vitro diagnostic/ medical device risk management, validation, usability
In vitro diagnostic/ medical device global RA
- Definition and classification of in vitro diagnostic/ medical devices in the US and Europe
- Understanding the US and European RA processes

※ Please note that the above curriculum is subject to change due to circumstances.




Education related matters

  • Completion criteria: 100% class attendance + 100% workshop participation
    ※ Behavior that disturbs other trainees may be subject to sanctions, and if the severity is severe, you may be expelled.
  • Certificate of Completion: Issued on-site on the same day after the completion of training
  • Inquiries : 02-6226-9775