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안녕하세요, 삶의 흔적을 남기는 감동 전문가 김영균입니다.
여러분께 마음을 드리고 싶었던 사람이 되고 싶습니다.
 

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<강의주제>

강의1- 4차 산업혁명 / 3시간]

강의2 - 의료기기 이론 및 실전 / 8시간] 

<자격 및 수료사항>

• KCLC 에니어그램 강사과정 수료 

• ISO 13485:2016 Internal Auditor
• 식품의약품안전처 심혈관의료기기과 전문가 협의체 – 소분과
• 국제성공과학연구원 강사트레이닝 코치

• Training for “Guide of Clinical Trial” by Korea Medical Device Industrial Coop. Association (2009)
• Training for “Clinical Trial Sponsor of Medical Device” by Korea Health Industry Development Institute (2012)
• Training for “Pre-Clinical Experiment Manager) by KFDA (2009)
• Training for “Institutional Animal Care and Use Committee” (2009)
• Training Course of ISO 13485 Advanced Awareness Training Course by SGS Korea
• Training Course for MDD 2007/47/EC by SGS Korea (2011)
• Training Course for MDD ISO 14971:2007 Risk Management by SGS Korea (2013)
• Training Course for FDA QSR, CMDCAS and JPAL requirements by SGS Korea (2013)
• Training Course for “Process Validation” by SGS Korea (2014)
• Training Course for “Technical Documentation Reviewer for Directive 93/42/EC” by SGS Korea (2015)
• Training Course for SFDA Regulatory Affairs by Korea Medical Device Industrial Coop. Association (2013)
• Training Course for “Quality Management of Medical Device” by Korea Medical Device Industrial Coop. Association (2015)
• Training Course for “Evaluation of new medical technology & Insurance Registration” by Korea Health Industry Development Institute (2013)
• Training Course for “Performance Evaluation of medical electrical equipment” by Korea Health Industry Development Institute (2013)
• Training Course for “New employee Basic Skills” by Global Business & Consulting
• Training Course for “Risk Management of IEC 60601-1 (3rd)” by Korea Testing Laboratory (2013)
• Technical Seminar for “IEC 60601-1 Edition 3.1” in UL Korea

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<주요 출강현황>

- 의료기기정보기술지원센터 전문가 협의체 4회
- 유앤아이 (KOSDAQ) 신입사원 교육 6회
- 유앤아이 협력업체 (17 社) 대상 RoHS 교육 17회
- 지쿱 신규 회원 교육 30회