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April 1, 2024
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SAMD Timeline
Criada
Mohammad Raza
⟶ Atualizado 15 mar 2018 ⟶
List of edits
Comentários
Eventos
Guidelines on SAMD
Mobile Medical Applications (MMA)
FDASIA Health IT Report
Medical Device Data Systems (MDDS)
21st Century Cures Act Clarifies (And Somewhat Reduces) Regulation of Stand Alone Software Products Used in Healthcare
Medical Device Development Tool (MDDT)
Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act
Clinical and Patient Decision Support (CDS) Software Draft Guidance
SaMD Clinical Evaluation Draft Guidance
IMDRF: Software as a Medical Device (SaMD): Key Definitions
IMDRF: Software as a Medical Device: Possible Framework
IEC 62304 Medical Device Software Standards – Software Life Cycle Processes
IMDRF: Software as a Medical Device (SaMD): Application of Quality Management System
IMDRF: Software as a Medical Device (SaMD): Clinical Evaluation
IEC-82304 Health Software – Part 1: General Requirements for Product Safety
MDR Regulation (EU) on Medical Device
Clinical Decision Support (CDS)