Tag - SaMD

Articles

SaMD Digital Technology Assessment Criteria (DTAC)
SaMD Post-Market Surveillance
MHRA Registration and Approved Bodies for SaMD
Conformity Assessment Route for Class III SaMD
Conformity Assessment Route for Class IIb SaMD
Conformity Assessment Route for Class IIa SaMD
Conformity Assessment Route for Class I SaMD
Essential General Requirements for Software as a Medical Device (SaMD) Conformity Assessment
Conformity Assessment Routes for Software as a Medical Device (SaMD)
SaMD Risk-Based Classification
Medical Device Claims & Intended Purpose
Is my software a medical device?
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