Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations
Title:
Software as a Medical Device": Possible Framework for
Risk Categorization and Corresponding Considerations
Origin/Publisher:
IMDRF
Document Type:
Guidance
Content:
The purpose of the document is to introduce a foundational approach, harmonized vocabulary and general and specific considerations, for manufacturers, regulators, and users alike to address the unique challenges associated with the use of SaMD