By deeply understanding the content of ISO 13485, this course will deepen the understanding of the specific requirements, risk analysis and evaluation, identification and traceability, feedback system, warning system, advisory notice, etc. related to the safety and effectiveness of medical devices. According to the basic principles of auditing, we can audit the internal quality management system, obtain audit evidence, and conduct a correct and objective audit evaluation of ISO 13485 system from the aspects of meeting the requirements of laws and regulations and maintaining an effective quality management system.

本课程将通过深入了解 ISO 13485 标准内容，加深理解医疗器械所特有的与产品安全性有效性有关的特定要求、风险分析和评估、标识与追溯、反馈系统、警戒系统、忠告性通知等；并能按照审核的基本原则，执行内部质量管理体系审核，获取审核证据，从满足法规要求、保持有效的质量管理体系等方面对 ISO 13485 体系进行正确客观的审核评价。

• 2022-12-12 - 2022-12-14 | 09:00 - 17:00
• Online webinar

The new EU Medical Device Regulation MDR (EU)2017/745, which replaces the previous MDD (93/42/EEC) directive and AIMD (90/385/EEC) directive, entered into force in May 2017 and became mandatory in May 2021. Compared with the current medical device directive, MDR adds many new regulatory requirements, such as the requirement of unique device identification (UDI), the requirement of regularly updating CE technical documents, and the requirement of post-market supervision. The transition period of MDR is very short, and this change is bound to have a significant impact on relevant Chinese medical device enterprises, which requires active response. This course provides guidance for organizations upgrading from MDD to MDR certification to customize and implement an independent CE conversion plan.

新的欧盟医疗器械法规 MDR (EU)2017/745 取代了之前的 MDD（93/42/EEC）指令和 AIMD（90/385/EEC）指令，已于 2017 年 5 月生效，并于 2021 年 5 月强制实施。相比现行医疗器械指令而言，MDR 增加了很多新的法规要求，比如：唯一器械标识（UDI）的要求、定期更新 CE 技术文件的要求、上市后市场监督的要求等。MDR 过渡期时间很短，此次变更势必对相关中国医疗器械企业造成重大影响，需要积极应对。此课程为 MDD 升级到 MDR 认证的企业提供指导，定制一套独立的 CE 转换计划并有效实施。

• 2022-12-12 - 2022-12-15 | 09:00 - 17:00
• Online Training

At present, the downward pressure on the economy is huge, operating costs are constantly increasing, orders are changing to small batches and multiple varieties, market competition is becoming more and more fierce, product iteration is accelerating, and uncertain factors in the external environment are increasing... What is the panacea to help Toyota maintain such prosperity The vitality of the world has created the myth of immortality that attracts the attention of the world? The answer is the Toyota lean management model.

当下，经济下行压力巨大，运营成本不断提升，订单向小批量多品种转变且市场竞争越演越烈，产品迭代加快，外部环境的不确定因素不断增多……是什么灵丹妙药帮助丰田汽车保持如此旺盛的生命力，创造了令世人瞩目的不老神话呢？ 答案是丰田精益管理模式。

• 2022-12-12 - 2022-12-15 | 13:00 - 16:30
• Online webinar

European Union Chamber of Commerce in China Shenyang Chapter in cooperation with AmCham China warmly welcomes you to join this year’s Christmas Market at Star Mall. We focus on families especially! 中国欧盟商会沈阳分会联合中国美国商会联合诚邀您加入今年在星摩尔购物中心的圣诞集市活动！我们的圣诞集市着重于家庭！

• 2022-12-10 | 10:00 - 20:00
• Star Mall Shenyang Plaza(People Square)

On Saturday 10th December, the European Union Chamber of Commerce in China (European Chamber) and the China Electric Power Planning & Engineering Institute (EPPEI) will co-host the Second China-Europe Energy Technology Innovation Cooperation Forum online.

中国欧盟商会和电力规划设计总院将于2022年12月10日（星期六）以线上形式联合举办第二届中欧能源技术创新合作论坛。

• 2022-12-10 | 14:00 - 17:30
• Online

As 2022 comes to a close, China’s economic outlook is the most uncertain since the country first embarked upon its programme of reform and opening more than four decades ago. Its COVID strategy has been put to the test, with nationwide outbreaks of the highly transmissible Omicron variant disrupting business operations on an unprecedented scale throughout the year. Other significant internal challenges include China’s mounting debt crisis, the unravelling of its real estate sector, demographic headwinds and stalling consumption growth.

• 2022-12-09 | 13:30 - 18:10
• Zoom Online/Grand Ballroom 1, 4F, InterContinental Beijing Sanlitun

[Online & Offline] Supply chain practical training [线上 & 线下] 供应链实战系列培训

• 2022-12-09 - 2022-12-31 | 09:00 - 18:00
• Online + European Chamber Office, 41 Floor, Meeting Room

Definition:
Your capacity to respond to life’s challenges with positive rather than negative mindset

Impact:
Peak performance
Peace of mind/wellness
Healthy relationships

• 2022-12-08 | 09:00 - 13:30
• Zoom online

Definition:
Your capacity to respond to life’s challenges with positive rather than negative mindset

Impact:
Peak performance
Peace of mind/wellness
Healthy relationships

• 2022-12-08 | 09:00 - 13:30
• Zoom online

Online Training - Core Talent Motivation and Retention 核心人才激励与保留 (中文授课)

• 2022-12-07 - 2022-12-08 | 13:00 - 17:00
• Tencent Meeting