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BS EN ISO 13485:2016+A11:2021
Medical devices. Quality management systems. Requirements for regulatory purposes
Medical devices. Quality management systems. Requirements for regulatory purposes
Vydáno: 2021-09-08
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BS EN IEC 81001-5-1:2022
Health software and health IT systems safety, effectiveness and security Security. Activities in the product life cycle
Health software and health IT systems safety, effectiveness and security Security. Activities in the product life cycle
Vydáno: 2026-04-09
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BS EN ISO 14971:2019+A11:2021
Medical devices. Application of risk management to medical devices
Medical devices. Application of risk management to medical devices
Vydáno: 2021-12-15
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PD ISO/TR 80001-2-6:2014
Application of risk management for IT-networks incorporating medical device Application guidance. Guidance for responsibility agreements
Application of risk management for IT-networks incorporating medical device Application guidance. Guidance for responsibility agreements
Vydáno: 2014-11-30
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BS ISO 20069:2019
Guidance for assessment and evaluation of changes to drug delivery systems
Guidance for assessment and evaluation of changes to drug delivery systems
Vydáno: 2019-08-07
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