BS EN ISO 13485:2016+A11:2021是关于什么的？本国际标准规定了医疗器械质量管理体系的监管要求。BBS EN ISO 1348 5:2016 +A11:2021是标准的2021修正案，其中包括新的附件，显示了标准条款和欧洲医疗器械法规和IVD医疗器械法规的要求之间的关系。BS EN ISO 13485:2016+A11:2021适用于谁？医疗器械制造商和医疗器械供应链中的其他组织，包括授权代表、进口商和经销商合格评定机构BS EN ISO 13485: 2016+A11:2021封面？它给出了医疗器械质量管理体系的监管要求。它为确保一致的设计、开发、生产、安装和交付产品提供了基础，这些产品在其预期用途中是安全的。它还协调了全球要求，并得到了世界各地许多司法管辖区的监管机构的认可。BBS EN ISO 13485于2016修订，2021年被确认为5年。为什么要使用BS EN ISO 13485:2016+A11:2021？它可以帮助您实施有效的医疗器械质量管理体系，持续生产安全有效的医疗器械。它可以帮助您证明符合监管要求。它可以进一步协调不同司法管辖区之间的监管要求，从而减少各个市场的独特要求。新附件制造商和通知机构进行差距分析，以确定需要注意哪些方面来补充标准，以满足新的欧洲要求。这使用户能够利用医疗器械质量管理体系和法规遵从性来发展他们的专业知识。这是管理风险、改进流程和效率的有效方法，它的使用可以增加人们对医疗设备的信任，从而带来一些竞争优势BS EN ISO 13485的新功能: 2016+A11:2021？这是对BS EN ISO 13485:2016的修订，增加了附录，将欧洲MDR和IVDR的要求与各法规中的质量管理体系要求进行了对比。每项法规都有自己的附件。每个附件包含三个表格。这三个表说明了标准中与标准的关系:制造商在第10条中的一般义务、附件九中的质量管理体系要求、基于质量管理体系的合格评定和技术文件的评估；质量管理体系要求在合格评定附件席中的要求基于产品符合性验证

What is BS EN ISO 13485:2016+A11:2021 about?This international standard sets out regulatory requirements for medical device quality management systems. BS EN ISO 13485:2016+A11:2021 is the 2021 amendment to the standard which comprises new annexes showing the relationship between the clauses of the standard and the requirements of the European medical devices regulations and IVD medical devices regulation.Who is BS EN ISO 13485:2016+A11:2021 for?Medical device manufacturers and other organizations in the supply chain for medical devices including authorized representatives, importers and distributorsConformity assessment bodiesWhat does BS EN ISO 13485:2016+A11:2021 cover?It gives regulatory requirements for quality management systems for medical devices. It provides the basis for ensuring consistent design, development, production, installation and delivery of products that are safe for their intended purpose. It also harmonizes global requirements and is recognized by regulators in many jurisdictions around the world.BS EN ISO 13485 was last revised in 2016 and in 2021 was confirmed for a further 5 years.Why should you use BS EN ISO 13485:2016+A11:2021?It can help you implement an effective medical device quality management system that consistently produces safe and effective medical devicesIt can help you demonstrate conformity with regulatory requirementsIt further harmonizes regulatory requirements between different jurisdictions and thereby decreases the number of unique requirements for individual marketsThe new annexes enable manufacturers and notified bodies to conduct a gap analysis to identify where attention is needed to supplement the standard to meet new European requirementsIt enables users to develop their expertise with a medical devices QMS and with regulatory complianceIt's an effective way to manage risk and improve processes and efficiencyUltimately, its use can increase trust in your medical devices and thereby confer some competitive advantageWhat's new about BS EN ISO 13485:2016+A11:2021?This is an amendment to BS EN ISO 13485:2016 which adds annexes mapping the requirements of the European MDR and IVDR against the requirements for quality management systems within each of the regulations. Each regulation has its own annex. Each annex contains three tables. These three tables map out the relationship of the standard with requirements in the regulation on:The general obligations of the manufacturer in Article 10The quality management system requirements in Annex IX on conformity assessment based on a quality management system and on assessment of technical documentationThe quality management system requirements in Annex XI on conformity assessment based on product conformity verification