Description

The Verification Document Package for Software as a Medical Device (SaMD) and Artificial Intelligence (Al) is meticulously crafted to assist organizations in implementing a comprehensive verification process in line with ISO 13485:2016, IEC 62304, and ISO 14971 standards.

This package includes:

• Verification Plan: A structured document detailing procedures for verifying product specifications, ensuring that design outputs meet the defined input requirements.
• Verification Report: A comprehensive summary compiling the results of verification activities, documenting whether the product specifications have been met.
• Excel Tools: User-friendly spreadsheets designed to aid in tracking and documenting verification processes.