ISO 13485:2013 is an international standard for medical devices that says what needs to be done to ensure the quality of medical devices. ISO 13485 is based on risk-based design and ensures that medical devices are safe and effective. It establishes minimum requirements for medical device design...
ISO 13485 is hugely important to designers, manufacturers, and distributors of medical devices. Adopting this standard provides an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and respons...
In the EU, the requirements of ISO 13485 have been harmonized with the essential requirements of the EU’s Medical Device Directive (93/42/EEC), the Directive for In Vitro Diagnostic Medical Devices (98/79/EC) and the Directive for Active Implantable Medical Devices (90/385/EEC). Certificati...
ISO 13485 is hugely important to designers, manufacturers, and distributors of medical devices. Adopting this standard provides an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and respons...
ISO13485是指标准化组织（International Organization for Standardization）制定的一项医疗器械质量管理体系标准，其全称是ISO 13485:2016《医疗器械——质量管理体系——要求的标准》（Medical devices—Quality management systems—Requirements for regulatory purposes）。 企业名片 该标准于2016年发布，是医疗器械行业中广泛...
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 13485:2016 specifies requirements for aquality management systemwhere an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.” ISO 13485 is intended to help medical device manufacturers (an...
7.**与其他标准的联系**:该标准与医疗器械相关的其他国际标准,如ISO1497:2008(风险管理原则和应用)、ISO14973:2006(医疗器械不良事件的识别和报告)等有密切联系。 ISO14971:2007FRMedicaldevices-Applicationofriskmanagementtomedicaldevices标准是医疗器械领域的重要指南,它提 下载文档 收藏 分享 赏 0您...
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