📄️ R-TF-012-033 Software Tests Plan
Test identification
📄️ R-TF-012-023 Software Development Plan
Project plan
📄️ 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.
📄️ 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.
📄️ 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
📄️ Design History File
The table below lists the specific versions (or commits) of the microservices that comprise this system-level version of the medical device. The components' versions shown in the table are a result of all the requirements detailed on this page. Additionally, system tests ensure that these software versions meet the specified requirements.