The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
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
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