This white paper provides an update of the proposed revisions to EU medical device regulation as of April 2014. BSI WP EU Regulations
This white paper provides an update of the proposed revisions to EU medical device regulation as of April 2014. BSI WP EU Regulations
IEC 62304 and other Emerging Standards Impacting Medical Device Software
Being Agile & Yet Compliant
ISO 14971 SaMD Risk Management
Software Risk Management
Medical Device Cybersecurity
Software Verification
IEC 62366 Usability Process and Documentation
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