📄️ R-TF-012-023 Software Development Plan
Project plan
📄️ R-TF-012-033 Software Test Plan
Purpose
📄️ R-TF-012-034 Software Test Description
Document Information
📄️ R-TF-012-035 — Software Test Report
Document Information
📄️ R-TF-012-038 Verified Version Release
Document Information
📄️ R-TF-012-039 Validated Version Transfer
Document Information
📄️ R-TF EN 62304 Checklist
This checklist provides a comprehensive review of compliance with the EN ISO 623042015 standard for medical device software lifecycle processes. The checklist is structured according to the major clauses of the standard and should be completed as part of the quality management system documentation for the device.
📄️ R-TF EN 82304 Checklist
This checklist provides a comprehensive review of compliance with the EN IEC 82304-1 General requirements for product safety. This standard applies to health software products intended to be used by patients or healthcare providers.