2021 SCH Medical Device CoE Training
September 1 st – 21 th , 2021 (9.7-hr course, available for 3 weeks)

• Design training programs that meet PWA CoE Program Committee’s training objectives in the scope of Total Product Life Cycle of Medical Devices
• Deliver training programs effectively and promote harmonization and advancement of the use of standards in the assessment of medical devices among APEC region
• Assess the implementation and outcomes of CoE training and provide suggestions for future regulatory harmonization activities APEC LSIF RHSC
• Secure programs and a pool of lecturers and experts to disseminate the importance of the use of standards

The 2021 SCH Medical Device CoE Training endeavor to train and educate ourselves of the topics across the total product life cycle of medical devices. The three main subject areas are Clinical Evaluation, Quality Management System and Medical Device Adverse Event. Through this training, we expect to expand our understanding of international standards, harmonize the regulatory systems for medical devices within APEC economies, build reliability on clinical tests conducted for medical devices, and thereby, share the benefits from the development of medical devices and healthcare with APEC economies.

• Regulators from APEC economies
• A wider range of stakeholders including academia, industry, etc

The training will be held virtually via video lectures and Untact Conference, due to COVID-19

• Certificates of participation will be issued to qualified trainees that have met the following minimum requirements:

  • Completion of 3 or more VOD lectures
  • Participation of 3 or more Online activity
  • Attendance of at least 1 Untact Conference
  • Completion of satisfaction survey

• Seungwoo Kim, Ph.D.
  President
  Soonchunhyang University

• Eung-jin Shin, M.D., Ph.D.
  President
  Soonchunhyang University Bucheon Hospital