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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

Overview of current consumer mood/sentiment in China and the sports Industry in a snapshot

  • 2022-12-09 | 10:30 - 11:30
  • 8F, T1, 118 Feihong Rd., Hongkou District, Shanghai (close to metro line 4 Linping Rd Station)
Members only

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

It is more common for companies involving in a public opinion crisis. A response to the public is necessary. Some companies accept media interviews, some send lawyer letters to media, and some post statements on their official websites and official accounts.
However, there are very few successful cases that can calm the public opinion with a single response. More often, the response got no attention at all, or even worse, the response triggers a new round of public discussion in a negative way. In this case, some companies are rather like to keep silent, which means giving up the chance of explanation.
In this lesson, we select and analyze the successful public opinion response of some crisis. By doing so, we will learn how to respond to public opinion.

  • 2022-12-02 | 09:00 - 17:00
  • Zoom online

It is more common for companies involving in a public opinion crisis. A response to the public is necessary. Some companies accept media interviews, some send lawyer letters to media, and some post statements on their official websites and official accounts.
However, there are very few successful cases that can calm the public opinion with a single response. More often, the response got no attention at all, or even worse, the response triggers a new round of public discussion in a negative way. In this case, some companies are rather like to keep silent, which means giving up the chance of explanation.
In this lesson, we select and analyze the successful public opinion response of some crisis. By doing so, we will learn how to respond to public opinion.

企业遇到舆情是越来越常见的情况。现在,很多企业都会对舆情做回应:有的接受媒体采访,有的发律师函,有的在自家官网和公号上发声明……
同样,能用一次回应平息舆情的成功案例非常少,更多时候,要不回应如泥牛入海,更糟的是回应引发新一轮舆情,越回应事情越大。
这种情况下,又有企业宁可采取“鸵鸟战术”:任你舆情滔天,我自一声不吭。
在本课中,我们精选那些成功的舆情回应声明,对其做解析,来分析和学习舆情时如何做回应的技巧。

  • 2022-12-02 | 09:00 - 16:00
  • Zoom 会议

The Agriculture, Food and Beverage Working Group is delighted to invite you to the working group meeting Navigating the landscape of handling professional consumers complaints in China – from the food law perspective.

  • 2022-11-28 | 15:00 - 16:10
  • Online
Members only
24
Nov
Shanghai > Working Group Meeting

National: Construction and R&D Joint Working Group Meeting

Technology is bringing atomic fission to mankind’s life nowadays. What will being’s future city be like enabled by blockchain, AI, and Internet of things? Although all the three new vehicles are still in its infancy development stage, and a lot of questions are yet to be answered, we see revolutions of machine learning, smart contracts, secured remote control, mobility solutions, visualized applications and accuracy positioning happening around globe-wide.

  • 2022-11-24 - 2022-11-24 | 14:00 - 16:00
  • Online via Zoom
Members only

中国欧盟商会石化, 化工和炼油工作组诚邀请您参加将于2022年11月24日(星期四) 14:00 - 17:00在上海市安全生产科学研究所合作单位(徐汇区田林路142号)以及线上举行的“新《安全生产法》及危化品登记和进口要求解读”会议。

  • 2022-11-24 | 14:00 - 17:00
  • Shanghai Institute of Work Safety Science上海市安全生产科学研究所 and Zoom
Members only