This document will provide a risk framework and identify elements of validation to include mechanisms to communicate the validation of device to the end users.
Designation of Proposed Standard:
CTA-2105
Title of Standard:
Reporting/Validation Framework for Cardiovascular Technology Solutions
Project Need:
To a risk framework and identify elements of validation to include mechanisms to communicate the validation of device to the end users.
Project Intent:
Create new ANS
Includes text from ISO or IEC standard?:
No
Scope Summary:
This document will provide a risk framework and identify elements of validation to include mechanisms to communicate the validation of device to the end users.
Keywords:
Cardiovascular Technology Solutions; Requirements; validation; digitial health
