IEC62304:2006-7- +AMD1:2015CSVIEC2015 AclivliesutsidetheopeofthisstandarcCustomerneeds Customerneeds satisfed 7Sof 5.15.55.65.7 SofwareSoftwareUNTSoftwareintegratiorSoftwareSYSTEN5.8 requirementsARCHITECTURALmplementationancandintegration planninganalysisdesignVERIFICATIONtestngtesting 9Sofwareproblemresolution IEC...
IEC 62304对软件项目(software items)的定义如下:计算机程序的任何可识别部分。因此,软件项目(software items)包括软件的所有部分,包括软件系统(software system)本身和所有软件单元(software unit)。术语软件组件(software components)通常与软件项目(software items)同义使用,但“软件系统(software system)”除外,它是一个...
概述:IEC 62304是医疗设备的安全标准,遵守该标准对软件开发商至关重要。使用parasoft C/c++ Test,将获得全面的自动化软件测试解决方案,其中包括广泛的测试方法,有助于满足IEC 62304法规遵从性要求。# 界面/图表报表/文档/IDE等千款热门软控件火热销售中 >> 相关链接:...
Automated unit and system level testing with test report generation IEC 62304 supported workflow for FDA/MDR regulatory compliance About the Presenter Dr. Visa Suomi is the Medical Devices Industry Manager at MathWorks. He has over 10 years of international experience in the life sciences ...
IEC 62304模板概要1.doc,Company: File No. File: 软件验证报告 Revised No. 1 软件验证报告 公司名称: Company Name: 公司地址: Company Address: 软件名称: Software Name: 版本号: Version number: 软件适用范围: Software Applications: 软件发布时间: Software
Software Testing for IEC 62304 Compliance Cantata allows developers to automate unit and integration testing and verify IEC 62304 compliant code on host native and embedded target platforms. By automating test framework and test case generation, test execution, and results diagnostics and report generatio...
Test Plan HAZOP reports API Usage review HAZOPS Report for MPU MPU API Usage Safety Review Investigation arising from HAZOPS Tools Register EN 62304 & ISO 14791 Compliance Matrix Customer Requirements Specifications Software Requirements Specifications ...
IEC62304 Reference SoftwareLifecycleProcess 55.15.1.15.1.25.1.35.1.45.1.55.1.65.1.75.1.85.1.95.1.105.1.115.25.2.15.2.25.2.35.2.45.2.55.2.65.35.3.15.3.25.3.35.3.45.3.55.3.65.45.4.15.4.25.4.35.4.45.5 PRIMARYLIFECYCLEPROCESESS SOFTWAREDEVELOPMENTProcess...
The Qualification Pack test procedures check the requirements under normal operating conditions. Each procedure provides input data that generates a validated pass/fail report for each checker. The tool is deterministic in its execution and generates the same output results for a given set of input ...
Integration test documentation contents task X X 5.6.10 Use formal software problem resolution PROCESS task X X 5.7 System Testing Activity 5.7.1 Establish tests for each software requirement task X X 5.7.2 Use formal software problem resolution PROCESS task X X 5.7.3 Repeat tests and conduct ...