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