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- 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
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ICMC (International Certification Management Center Co., Ltd.)
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MDD 93/42/EEC Annex I Essential Requirements
12. Requirements for medical devices connected to or equipped with and energy source
12.1a For devices which incorporate software of which are medical software in themselves, the software must be validated according to the state of the are taking into account the principles of development lifecycle, risk management, validation and verification.
MDD 93/42/EEC Annex I Essential Requirements
12. Requirements for medical devices connected to or equipped with and energy source
12.1a For devices which incorporate software of which are medical software in themselves, the software must be validated according to the state of the are taking into account the principles of development lifecycle, risk management, validation and verification.
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