qms_version 2.2.0 sop_id sop_version template_id CSC F.025 template_version 2.0.1 record_version record_id DE-001 title Documentation-level evaluation Documentation-level Evaluation General Template ID CSC F.025 Template Version 2.0.1 QMS Version 2.2.0 SOP ID SOP Version Regulatory References Author Approval Purpose and Scope This document evaluates the level of documentation required for the classification of medical device. This document applies to {{device.name}} release {{device.version}}. Definitions Item Definition Justification [TODO: The level of documentation required depends on the classification of the device ]