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)

Communication and teamwork skills have never been more essential to personal success! 75% of a person's success depends on communication, 25% on talent and ability. For enterprises, people are more and more emphasis on the establishment of learning enterprises, more and more emphasis on the spirit of teamwork, so effective internal communication is the key to success; For external, in order to achieve the combination between enterprise and the complementary advantages, people need to grasp the negotiation and cooperation and communication skills; For enterprises themselves, in order to better realize the development of enterprises and serve the society under the existing policy conditions, they also need to handle the relationship between enterprises and the government, enterprises and the public, enterprises and the media and other aspects. These are inseparable from mastering and applying the principles and skills of management communication. For individuals, it is obviously very important to establish a good sense of management communication and gradually develop the habit of consciously applying management communication theories and skills to effectively communicate in any communication situation, so as to achieve twice the result with half the effort. Learning communication skills will make you more comfortable in work and life.

沟通与团队合作能力从来没有像现在这样成为个人成功的必要条件！一个人成功的因素75％靠沟通，25％靠天才和能力。对企业内部而言，人们越来越强调建立学习型的企业，越来越强调团队合作精神，因此有效的企业内部沟通交流是成功的关键；对企业外部而言，为了实现企业之间的强强联合与优势互补，人们需要掌握谈判与合作等沟通技巧；对企业自身而言，为了更好地在现有政策条件允许下，实现企业的发展并服务于社会，也需要处理好企业与政府、企业与公众、企业与媒体等各方面的关系。这些都离不开熟练掌握和应用管理沟通的原理和技巧。对个人而言，建立良好的管理沟通意识，逐渐养成在任何沟通场合下都能够有意识地运用管理沟通的理论和技巧进行有效沟通的习惯，达到事半功倍的效果，显然也是十分重要的。学习沟通技巧，将使您在工作、生活中游刃有余。

• 2022-12-08 | 20:00 - 21:00
• Online Webinar

When managers formally report to leaders or cross-departmental teams in stressful meetings, the biggest challenge is how to: get to the point and get support; be logical and organized; be concise and focused.

管理者在充满压力的会议中，向领导或者跨部门团队做正式汇报的时候，最大的挑战莫过于如何：切中要害，获取支持；逻辑性强，富有条理；简明扼要、突出重点。

• 2022-12-06 | 15:00 - 16:30
• Online webinar

According to research, the peak performance of an organization requires the trust, participation and mutual support of each member in the work, and the realization of high-value outputs through effective methods and processes. In this course, through the response of OKR work method, it can effectively help organizations to improve the focus on target points, effectively promote organizational collaboration, work and innovation, and thus improve organizational vision cohesion and high performance output.

据研究，组织达到巅峰表现，需每位成员工作中批次信任、共同参与和相互支持，并通过有效的方法和流程达成高价值产出。在本课程中，通过 OKR 工作法的反响，有效帮助组织提升聚焦目标要点、促进组织协同、有效推进工作、促进创新挑战，进而提升组织愿景凝聚力和高绩效产出。

• 2022-12-02 | 15:00 - 16:30
• Online Webinar

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

With the arrival of a large number of post-1995-00 employees, they bring a new atmosphere to the enterprise, but also make the traditional management model more and more impractical. How to understand the inner needs of employees after 1995-00 has become an important problem in today's enterprise management. As middle-level and grass-roots managers, how to break through the inter-generational contradiction, strengthen their own management ability, reduce the turnover rate of enterprise talents, and improve organizational performance?

随着 95-00 后职场大军的大批来袭，个性张扬的他们在给企业带来新气象的同时，也让传统的管理模式越来越行不通了。如何破解 95-00 后员工心灵密码，成为了现今企业管理的一个重要难题。作为公司中层，基层的管理者，又如何突破代际矛盾，加强自身管理能力，降低企业人才流失率，提高组织绩效呢？

• 2022-11-30 | 16:00 - 17:00
• Online Webinar

两个现象：
企业往往将产品质量归结为质量部门的责任；
质量提升过程中，其他职能部门认为是在辅助质量部门的工作；
一种无奈：
质量部门通常对其他部门的质量工作参与度感到无奈；

此课程培训目的：
1，通过全面质量管理的理念的讲解，让学员清楚的了解企业产品或服务的质量全面管理的核心理念；
2，通过全面质量管理的流程梳理，帮助学员分析并掌握全面质量管理的实施方法；
3，通过全面质量管理的工具训练，让学员掌握改善质量的实用工具；
最终帮助企业建立起全员的质量意识、建立全流程质量提升的方法，提升企业整体质量管理水平，降低质量成本。

• 2022-11-24 - 2022-11-25 | 09:00 - 17:00
• Online training (2 days)