BSI — Software as a Medical Device (SaMD) Classification and Certification

NB White Paper BSI Group (NB 2797) 2023-06-01
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Summary

BSI’s guidance on classifying and certifying software under EU MDR, including IEC 62304 software lifecycle considerations, MDCG 2019-11 qualification rules, and cybersecurity requirements for connected medical device software.

Document Details

Document IDBSI-SAMD-GUIDE
TypeNB White Paper
AuthorityBSI Group (NB 2797)
Publication Date2023-06-01

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TypeNB White Paper
Published ByBSI Group (NB 2797)
Date2023-06-01

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