The video provided below shows you exactly what you will receive when you purchase our Software Validation Procedure (SYS-044). The procedure is intended to meet the requirements of ISO 13485:2016, Clause 7.3.6 and 7.3.7 for design verification and design validation of medical device products. This procedure is also intended to meet the requirements of IEC 62304, ed. 1.1 and 21 CFR 820.30(a)(2)(i) and (g).
SYS-044 Software Development and Validation Procedure
Теги
standard operating proceduresSOPIEC 62304IEC 62304:2016software validation procedureSYS-044medical device academyprocedureISO 13485:2016software developmentFDA regulationsSaMDsoftware as a medical devicesoftware architecturesoftware requirements specificationSRSlevel of concernLOCV-diagramagile programmingSOUPsoftware of unknown prevenancecybersecuritypost-market surveillance of cybersecuritysoftware risk management
