The AssurX medical device quality management system integrates core quality processes. It includes complaint management, CAPA, deviations, document control, training management, audit management, and change management. Having a single repository for all quality documents enables users to quickly find the ...
A Medical Device Quality Management System (QMS) is a framework that ensures compliance while fostering innovation at the speed required to compete on a global scale. It requires streamlined, agile quality processes that quickly close the loop on medical device quality problems. Big players in the ...
【英语版】国际标准 ISO 13485:2003 EN 医疗器械 质量管理体系 监管要求 Medical devices — Quality management systems — Requirements for regulatory purposes.pdf,ISO 13485:2003 EN 是医疗器械质量管理体系的国际标准,用于法规目的。这个标准主要涵盖了医疗器械行业
ISO 13485 is the medical device industry's quality management system (QMS) standard; written to specify requirements for an organisation to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and appl...
Discover BSI Group's medical devices capabilities, offering standards and certifications for medical device safety and performance.
The system is provided with advanced quality management models, conforms to the national Medical Device Production Quality Management Standard and an international Medical Device Quality Management System Standard 134851, is integrated with quality management systems of America and European Union and provides...
青云英语翻译 请在下面的文本框内输入文字,然后点击开始翻译按钮进行翻译,如果您看不到结果,请重新翻译!MMEDICAL DEVICES-QUALITY MANAGEMENT SYSTEM -REQUIREMENTS FOR REGULATORY PURPOSES选择语言:从 到 翻译结果1翻译结果2 翻译结果3翻译结果4翻译结果5 翻译结果1复制译文编辑译文朗读译文返回顶部 mmedical设备的质量...
Intertek Academy learning helps you understand, implement, and improve your business with management systems and compliance training. Go To Intertek Academy SAHPRA Recognized QMS Certificates Intertek Medical Notified Body AB has registered with SAPHRA in recognition of SWEDAC accredited ISO 13485 certificat...
ISO 13485: Quality Management System for Medical Devices (78115), organized by Management Forum. Find conference details | Conference Locate (Clocate)
This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Key Features Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to...