![DNV MEDCERT certification services](/siteassets/images/dnv-medcert-certification-services_1134x300.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
Medical devices
![Medical devices](/siteassets/images/medical-devices---service-line---1134x300.jpg?mode=crop&scale=both&quality=90&format=webp&width=768)
Medical devices are subject to strict regulatory processes to enter the market. Manufacturers need to show compliance with the corresponding requirements and standards which needs to be certified by an independent organization. DNV has two certification and notified bodies which offer a wide range of services to suit your needs – DNV Product Assurance and DNV MEDCERT.
![DNV MEDCERT certification services](/siteassets/images/dnv-medcert-certification-services_1134x300.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
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ISO 13485 - 의료기기 품질 경영
![ISO 13485 – Medical devices quality management](/siteassets/images/iso-13485-261x100.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
ISO 13485 – Medical devices quality management
![Medical Devices Regulation (EU) 2017/745 - MDR](/siteassets/images/medical-device-training-261x100.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
Medical Devices Regulation (EU) 2017/745 - MDR
![Access the Medical Devices Global Market – MDSAP](/siteassets/images/cmdcas_261x100.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
Access the Medical Devices Global Market – MDSAP
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EO 멸균 밸리데이션 과정
![ISO 13485:2016/MDR 내부심사원 과정_CAPA포함](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
ISO 13485:2016/MDR 내부심사원 과정_CAPA포함
![ISO 14971:2019 & ISO/TR 24971:2020 위험경영 [IVDR]](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
ISO 14971:2019 & ISO/TR 24971:2020 위험경영 [IVDR]
![ISO 14971:2019 & ISO/TR 24971:2020 위험경영 [MDR]](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
ISO 14971:2019 & ISO/TR 24971:2020 위험경영 [MDR]
![ISO 14971:2019 & TR24971:2020 의료기기 위험 관리 과정](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
ISO 14971:2019 & TR24971:2020 의료기기 위험 관리 과정
![IVDR CE기술문서 작성](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
IVDR CE기술문서 작성
![IVDR PMS 시스템 구축[ISO/TR 20416:2020 적용]](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
IVDR PMS 시스템 구축[ISO/TR 20416:2020 적용]
![IVDR 설계 관리 및 설계 밸리데이션](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
IVDR 설계 관리 및 설계 밸리데이션
![IVDR 성능평가(PE) 작성 과정 [MDCG 기반]](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
IVDR 성능평가(PE) 작성 과정 [MDCG 기반]
![MDR (EU 2017/745)을 반영한 품질시스템의 구축 및 이해 과정](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
MDR (EU 2017/745)을 반영한 품질시스템의 구축 및 이해 과정
![MDR / IVDR 사용적합성 프로세스 적용](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
MDR / IVDR 사용적합성 프로세스 적용
![MDR PMS 시스템 구축[ISO/TR 20416:2020 적용]](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
MDR PMS 시스템 구축[ISO/TR 20416:2020 적용]
![MDR 설계 관리 및 설계 밸리데이션](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
MDR 설계 관리 및 설계 밸리데이션
![MDR 요구사항 이해 및 실무적용](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
MDR 요구사항 이해 및 실무적용
![MDR 요구사항 해설 및 기술문서 과정](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
MDR 요구사항 해설 및 기술문서 과정
![MDR 임상평가(CE) 작성 [MEDDEV 2.7.1 Rev. 4 기반]](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
MDR 임상평가(CE) 작성 [MEDDEV 2.7.1 Rev. 4 기반]
![MDR적용을 위한 품질시스템의 구축 및 문서화 과정](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
MDR적용을 위한 품질시스템의 구축 및 문서화 과정
![MDSAP 요구사항 이해 및 실무적용 [MDR & IVDR]](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
MDSAP 요구사항 이해 및 실무적용 [MDR & IVDR]
![Steam & Radiation 멸균 밸리데이션 과정](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
Steam & Radiation 멸균 밸리데이션 과정
![생물학적 안전성 평가방법 및 평가보고서 작성 과정](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
생물학적 안전성 평가방법 및 평가보고서 작성 과정
![의료기기 CAPA 시스템 구축](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
의료기기 CAPA 시스템 구축
![의료기기 공정 밸리데이션 심사대응 과정](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)
의료기기 공정 밸리데이션 심사대응 과정
![클린룸 밸리데이션 (Cleanroom Validation) 과정](/siteassets/images/system/fallback-images/trainings.jpg?scale=both&format=webp&mode=crop&width=640&height=368)