Quality is paramount when it comes to healthcare, and ensuring the quality and safety of medical devices has always been a top priority for businesses.

In recent years, the domestic market has faced significant competition, leading more and more enterprises to expand their operations overseas. Due to the advantages of better exploring international markets, reducing costs, and enhancing global competitiveness, many businesses have opted to establish overseas factories. However, different countries have varying regulations and legal requirements, as well as differences in quality standards for medical devices. Therefore, enterprises should conduct comprehensive planning and strategic considerations when making early-stage decisions about establishing factories.

Regardless of whether a factory is built overseas or in the United States, it cannot escape the influence of natural disasters, political and economic factors, and other relevant external forces. In addition to external factors, internal issues within suppliers, such as the frequent recalls of faulty medical devices in early 2024, can lead to supply chain disruptions. This has prompted companies to consider strategies for enhancing supply chain resilience. Even when such events are avoided, a company’s supply operations cannot continue smoothly on their own. It is crucial to enhance the enterprise’s ability to tolerate risks and build resilience in order to mitigate and minimize the impact of supply chain disruptions.

With the rapid advancement of artificial intelligence, production methods have progressed from the early stages of automation 1.0 to the current era of 3.0. There is a growing trend among companies to seek ways to cut costs and enhance efficiency and sustainability. Simultaneously, ensuring the quality of products, especially the safety and efficacy of medical devices, remains a top priority. How can companies manage effectively from the production end to improve competitiveness and achieve desired goals?

This summit has invited experts from various sectors to discuss and analyze the current hot topics in the industry, providing the latest information on standards related to medical device regulation and quality management. Additionally, they aim to develop effective implementation strategies for the attendees.