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Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive

机译：软件过程改进，以帮助医疗设备软件开发组织遵守医疗设备指令的修订案

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peer-reviewed

机译：同行评审

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作者
Mc Hugh, Martin; Mc Caffery, Fergal; Casey, Valentine;
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年度 2012
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正文语种 eng
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1. Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive [J] . Mchugh M., Mccaffery F., Casey V. Software, IET . 2012,第5期

机译：软件过程改进，以帮助医疗器械软件开发组织遵守医疗器械指令的修订案
2. Process of Designing Robust, Dependable, Safe and Secure Software for Medical Devices: Point of Care Testing Device as a Case Study [J] . Sivanesan Tulasidas, Ruth Mackay, Pascal Craw, Journal of Software Engineering and Applications . 2013,第9期

机译：用于医疗设备的健壮，可靠，安全的软件设计过程：现场护理测试设备案例研究
3. The Impact of Regulatory Compliance on Agile Software Processes with a Focus on the FDA Guidelines for Medical Device Software [J] . Hossein Mehrfard, Abdelwahab Hamou-Lhadj International journal of information system modeling and design . 2011,第2期

机译：法规遵从性对敏捷软件过程的影响，重点关注FDA医疗设备软件准则
4. Medical Device Software Process Improvement A Perspective from a Medical Device Company [C] . Marie Travers, Ita Richardson International Conference on Health Informatics . 2015

机译：医疗设备软件过程改进了医疗器械公司的角度
5. Medical Device Recalls: The Need for an Updated Protocol in the 510k Approval Process for Medical Device Safety and Efficacy [D] . Boles, Kelly D. 2020

机译：医疗设备召回：在510K批准过程中需要更新的协议，用于医疗器械安全性和疗效
6. Mobile Software as a Medical Device (SaMD) for the Treatment of Epilepsy: Development of Digital Therapeutics Comprising Behavioral and Music-Based Interventions for Neurological Disorders [O] . Pegah Afra, Carol S. Bruggers, Matthew Sweney, 2018

机译：移动软件用于治疗癫痫的医疗设备（SaMD）：数字疗法的开发该疗法包括行为和基于音乐的神经系统疾病干预
7. Software Process Improvement to assist Medical Device Software Development Organisations to comply with the amendments to the Medical Device Directive\ud [O] . Mc Hugh, Martin, McCaffery, Fergal, Casey, Valentine 2012

机译：软件过程改进，以帮助医疗设备软件开发组织遵守对医疗设备指令的修订\ ud

Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive

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