medical devicesquality system regulation (QSR)risk analysisThe recent guidance on 21 CFR 11, the upcoming deadline for European CE Marking, and the needs of quality system regulation (QSR) have generated much d
objectives, and should provide a roadmap for validation activities, including testing, documentation, and communication. These documents should be updated throughout the development cycle, reflecting changes in the system’s functionality or regulatory requirements. ...
英文名称:Medical device software - Part 2: Validation of software for medical device quality systems 标准状态:现行 发布日期:2017-06-13 文档简介 该标准是一套用于医疗设备软件质量系统的软件验证的标准,适用于医疗设备软件的开发、测试和确认。以下是该标准的主要内容: 1.验证的目的和范围:该标准旨在为医疗...
ISO/TR80002-2:2017ENMedicaldevicesoftware—Part2:Validationofsoftwareformedicaldevicequalitysystems提供了一套全面的、系统的软件验证方法,以确保医疗设备软件的性能和安全性符合预期,从而确保医疗设备的整体质量和安全性能。
Design and Development:The design and development phase involves developing the medical device, including the software, hardware, and other components. This phase also involves creating the device specifications, design documents, and verification and validation plans. ...
内容提示: © ISO 2017Medical device software —Part 2: Validation of software for medical device quality systemsLogiciels de dispositifs médicaux —Partie 2: Validation des logiciels pour les systèmes de qualité des dispositifs médicauxFirst edition2017-06Reference numberISO/TR 80002-2:2017(E)...
This just-published book is written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.ARM Techcon...
FDA Software Validation软件验证指南
All-in-one testing from our medical software QA team From specific feature assessment to end-to-end quality validation reinforced with proficient project management, a1qa offers diversified strategies for testing software for devices in the healthcare domain. Functional testing We will examine whether...
Blog about software medical devices and their regulatory compliance. Main subjects are software validation, IEC 62304, ISO 13485, ISO 14971, CE mark 93/42 directive and 21 CFR part - page 1