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유럽 의료기기 CE MDR
[CE/MDD] Software 요구사항
- 관리자
- 2017-02-03 19:22:00
- hit611
- 112.161.21.76
소프트웨어나 소프트웨어 포함하는 의료기기의 경우 아래 사항을 만족시켜야 합니다.
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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