English
Korean- CUSTOMER
- ABOUT ICMC
- DOMESTIC RA
- GLOBAL RA
-
ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
- CUSTOMER
- ABOUT ICMC
- DOMESTIC RA
- GLOBAL RA
-
ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
- CUSTOMER
- ABOUT ICMC
- DOMESTIC RA
- GLOBAL RA
-
ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
ICMC NEWS & LIBRARY
ICMC (International Certification Management Center Co., Ltd.)
-
ICMC NEWS & LIBRARY
-
CE MDR
icmcert@naver.com
+82-2-851-3111
CE MDR
CE MDD 소프트웨어의 요구사항
- Admin Hits:1412
- 2011-04-18 18:38:00
소프트웨어나 소프트웨어 포함하는 의료기기의 경우 아래 사항을 만족시켜야 한다.
부속서 I 필수요구사항
12. 동력원에 연결 또는 장착하고 있는 의
료기기에 대한 요구사항
12.1.a 소프트웨어나 의료 소프트웨어를 내
포하고 있는 기기의 경우, 그 소프트웨어는
반드시, 개발 라이프사이클, 위험관리, 유효
성 확인 및 검증의 원칙을 고려한 기술적
수준에 따라서, 승인되어야 한다.
SNS sharing
TOP
- Company : ICMC (International Certification Management Center Co., Ltd.)
- CEO : Bong Ju Kim
- Address: 16 Digital-ro 32-ga-gil, Guro-gu, Seoul (Guro-dong) Partner Tower 2nd Room 1001.
- TEL : +82-2-851-3111
- FAX : +82-2-2028-3115
- BIZ NO : 214-88-14891
- EMAIL : icmcert@naver.com
10004 certified- 27701 Certified
- Copyright(c) ICMC International Certification Management Center. All Rights Reserved.
