ISO 13485 "Medical Device Quality Management System-Requirements for Regulations" is a quality management system standard for the international medical device industry. Since the upgrade was launched in 2010, after 6 preparations and comments, the new standard has been officially released on March 1, 2016. The new standard incorporates feedback from the medical industry, global experts and competent authorities. BSI, as the UK national standards body and the world's leading announcement body, participated in and provided technical input for the upgrade process.
The new standard adds a large number of best practices in the medical device industry and is compatible with the requirements of national medical device regulations including the US FDA, Japanese JPAL and Brazilian ANVISA GMP. The new standard can help improve the independent research and development capabilities of devices, ensure the safety and effectiveness of medical devices, and enhance the competitiveness of medical device companies.
This course is designed for medical device industry personnel. Participants will fully understand the requirements of the ISO 13485: 2016 quality management system and understand the ISO 14971: 2009 standard-"Relevant concepts of risk management in medical devices".
In-depth understanding of audit principles and how to apply ISO 19011: 2002 standards to perform effective internal audits through group activities, audit exercises, interactive discussions, and coaching courses.


ISO 13485《医疗器械质量管理体系-用于法规的要求》是国际医疗器械行业的质量管理体系标准。自 2010 年启动升版以来，经过 6 的准备和征求意见， 新标准已经于 2016 年 3 月1日正式发布。 新标准融入了医疗行业、全球专家和主管当局的反馈意见。 BSI 作为英国国家标准机构，以及全球领先的公告机构，全程参与并提供了升版的技术输入意见。
新标准增加了大量医疗器械行业最佳实践，兼容了包括美国 FDA, 日本 JPAL 和巴西ANVISA GMP 等国家医疗器械法规的要求，是一部将质量管理体系和法规注册及监管更加紧密结合的标准。新标针对设计和研发等要求可以帮助提升器械自主研发能力，并保证医疗器械的安全有效，从而提升医疗器械企业的自身竞争力。
本课程专为医疗器械行业人员而设。 学员将全面理解 ISO 13485:2016 质量管理体系的要求并了解 ISO 14971:2009 标准——“风险管理在医疗器械的应用的相关概念”。
通过小组活动、审核演练、互动讨论和教练式课程等方式深入理解审核原则和如何应用ISO 19011:2002 标准来执行有效的内审。

参加对象：
• 质量部经理
• 法规部经理

• 2020-05-18 - 2020-05-19 | 09:00 - 17:00
• Online - Zoom Platform

In October 2016, IATF 16949:2016 was published by IATF and is superseding and replacing the current standard of ISO/TS 16949, for defining requirements of a quality management system for organizations in the automotive industry.
The new standard has been aligned with and refer to the latest ISO quality management system standard, ISO 9001:2005. IATF 16949:2016 has followed ISO9001:2015 standard structure and requirements. IATF 16949:2016 is not an independent quality management standard, but implemented as a supplement and joining with ISO 9001:2015.

• 2020-05-18 - 2020-05-21 | 09:00 - 17:00
• Online via Zoom

国际上，ITIL® 资格认证被称为“IT 界的MBA“，众多的IT 人士将ITIL® 国际资格证当做其职业生涯的一个阶梯，ITIL® 认证目前已成为全球IT 行业抢手的资格认证之一。对IT 企业，IT 咨询企业以及众多实施信息化战略的企业IT 人员而言，也将是一份重要的“身份证明”。ITIL 在IT 服务管理领域已经成为最为实用的方法论，被全世界所认可和实践。2019 年ITIL 与时俱进的延续v3 精华的基础上发布了ITIL4. 新的ITIL 4 迈出重要一步，涵盖了最新的IT 服务发展趋势.

• 2020-05-16 - 2020-05-17 | 09:00 - 16:00
• Online

The European Union Chamber of Commerce in China is thrilled to invite you to participate in the "Seventh Badminton Training of 2020 EUCCC-SY” on May 16th from 14:00 to 16:30.中国欧盟商会荣幸的邀请您参加5月16日14：00-16：30的“2020欧盟商会沈阳分会羽毛球友谊赛第七次练习活动”。

• 2020-05-16 | 14:00 - 16:30
• Angli Information Park昂立信息园

As the largest market in Asia for the EU and the UK, China is equally important to both. But even before the Brexit vote had taken place, the UK appeared keen to form a relationship with China that would be distinct from the EU’s. In 2015, then-prime minister David Cameron hailed the coming ‘golden era’ of UK-China relations, and photos of him drinking Greene King ale in his local pub with President Xi Jinping were widely publicised. Post-Brexit, the UK embarked on a delicate balancing act of disentangling itself from the EU, simultaneously distancing itself from certain sensitive political issues in order to advance economic ties with China, while trying to stay close to Europe on key issues.

• 2020-05-15 | 15:00 - 16:30
• Online

Managing discussions and communication is one of the most challenge task we encounter everyday. A good tool of internal casual communication aside from emails and official phone calls could help a team to better communicate, to raise work effeciency and to enpower staff; a bad one would lead to a desaster.
We have been struggled for the past years for improving this situation; today, I would like to share my experiences of how we could able to manage to create and maintain a better internal communication.

• 2020-05-15 | 16:00 - 17:00
• Online via ZOOM

The European Chamber is pleased to welcome you back with a networking dinner at an outdoor venue. Here we can undo the stress of months under isolation with some laughs, drinks, and well-needed networking. Take the load off and come join us on May 15!
Don't worry, we all agree to not shake hands!

• 2020-05-15 | 19:00 - 21:30
• BAIA BURGER CONCEPT, A2303, 3rd Floor, 2nd Building Section A, Sea World

The R&D Working Group is delighted to invite you to the next working group meeting, a dialogue session with the Science and Technology Commission of Shanghai Municipality (STCSM) from 14:00-16:00 on 15 May 2020 in the European Chamber Shanghai Office.

• 2020-05-15 | 14:00 - 16:00
• European Chamber Office Shang'hai

Please join us on 14th May for a discussion with Bert Hofman, Director of the East Asian Institute at the National University of Singapore, Professor in Practice Lee Kuan Yew School, and former head of the World Bank in China; Zhu Ning, Professor and Deputy Dean at The National Institute of Financial Research (NIFR), Tsinghua University, and author of China’s Guaranteed Bubble; and Robin Zhu, Senior Analyst at Bernstein Asia Autos. Mr Joerg Wuttke, President of the European Chamber, will host and moderate this discussion.

• 2020-05-14 | 15:00 - 16:30
• Online

Please join us on 14th May for a discussion with Bert Hofman, Director of the East Asian Institute at the National University of Singapore, Professor in Practice Lee Kuan Yew School, and former head of the World Bank in China; Zhu Ning, Professor and Deputy Dean at The National Institute of Financial Research (NIFR), Tsinghua University, and author of China’s Guaranteed Bubble; and Robin Zhu, Senior Analyst at Bernstein Asia Autos. Mr Joerg Wuttke, President of the European Chamber, will host and moderate this discussion.

• 2020-05-14 | 15:00 - 16:30
• Online