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In recent years, the medical device industry has become a key emerging sector. The three-year COVID-19 pandemic has accelerated the rise of the medical device industry, making it a focal point for national industrial development. This seminar, jointly organized by the Plastics Center and National Yang Ming Chiao Tung University, will explore innovative technological applications and analyze the future trends of medical device development. Topics will include how medical device manufacturing can meet sustainable net-zero carbon emissions, the design and surface treatment technologies for invasive microcatheters, and the application of AI in various medical devices. The seminar aims to help industry players develop innovative medical products that are more aligned with future market demands and enhance industry competitiveness.

National Yang Ming Chiao Tung University and the National Science and Technology Council's Smart Medical Device Development and Testing Verification Service Platform (CIBDS Lab) have formed an alliance. They are inviting experts from the global smart medical field to organize an international seminar focused on cross-national, innovative, and biomedical visions. The goal is to create an academic exchange and industry development matchmaking platform. The seminar will also feature a press conference on industry-academia collaboration alliances. We sincerely invite all reporters to attend.

The International Biomedical Technology Research Alliance (B.I.T) is a group of members with biomedical engineering backgrounds who are passionate about smart healthcare. They initiate the i2i model (Initiative to Institution) to connect biomedical practice platforms, cross-disciplinary industry-government-academia collaboration, and promote biomedical innovation while cultivating interdisciplinary teams for biomedical entrepreneurship.

To build a communication bridge between domestic and international NGOs, B.I.T has gathered big data engineers, specialists, entrepreneurs, data scientists, designers, and other professionals who are enthusiastic about smart healthcare. By leveraging their resources and approaching the issues from various angles, they aim to solve real-world healthcare and medical problems.

The B.I.T Research Team focuses on helping healthcare professionals and collaborating with multiple medical alliances to inspire innovative solutions for smart healthcare. The team also trains and recruits globally competitive talents in smart healthcare, strengthens medical AI technologies, assists community members in publishing numerous international journal papers, and develops research capacity in smart healthcare. The ultimate goal is to bring biomedical industries to fruition and enhance the quality of medical care.

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Organizer：BIT Research Alliance & CIBDS Lab
Guiding Organizations：National Science and Technology Council (NSTC)、NYCU
Date：2022/10/23 9:30-17:30 (GMT+8)
Location：NYCU Activity Center, Conference Room 2 (No. 155, Section 2, Linong Street, Beitou District, Taipei City)
Event Format：The event will be held both online and offline. A press release link will be provided after the event.
Media Registration Link：https://forms.gle/beM3DAzCr57Hwgv99

Latest Regulatory Course Sharing - Smart Medical Device Regulations Course
 

This seminar will explore the integration of three sensory technologies—auditory, speech, and visual—with AI, to deeply examine the professional knowledge and expertise that clinical personnel use in applying sensory interactions such as vision, hearing, and speech in medical diagnosis, treatment, and patient interactions within the field of smart medical devices. The aim is to enhance the value and functionality of the multi-sensory smart medical devices being developed.

If you are interested in hearing more experience sharing and participating in live interactions, we warmly invite you to register and join us！

Smart Medical Devices Series: May 4, 2022 - Preparation of Medical Device Registration Documents and Procedure Management: Practical Guide for FDA Registration Submission

★Lecture Title: Applications of Artificial Intelligence in Innovative Medical Devices and Biomedical IoT
★Speaker: Mr. Chien-Sheng Liu, CEO of Lichuang Biomedical Technology Co., Ltd.
★Lecture Time: April 27 (Wednesday), 12:00 PM - 1:00 PM (20 min presentation / 10 min Q&A)
★Meeting Link: https://nycu.webex.com/nycu/j.php?MTID=m793f30ab4b8fae6b20118c15592fe8be


 

With the close integration of healthcare and technology, the demand for "patient-centered" healthcare services has increased in recent years. The intelligence of systems has become a key pursuit for hospitals. The emergence of "smart wards" has also driven the digital transformation of traditional hospital care. Not only do smart wards effectively improve the efficiency of healthcare processes, but they also enhance patient safety and provide the most appropriate medical care for patients.


In this trend, Advantech will invite hospital partners and industry peers to share insights on the pain points and challenges of building smart wards on March 25, 2022, at 10 AM. In addition, we are honored to invite Southeast Asian partners to share their experiences on the construction of smart hospitals in Vietnam and the current state of smart healthcare development in the country.

We sincerely invite those interested in smart wards and smart healthcare to join us online for this exchange. Together, we aim to create larger-scale, specialized, and global smart ward solutions, further enhancing the quality of healthcare in Taiwan.

We welcome you to register and participate immediately. Let's meet online and discuss the development and challenges of smart wards and smart healthcare!

Medical Device Design and Development (Design Controls) Quality System




Course Objectives
Understand how design activities should be conducted to meet design control requirements. Learn how to apply the specific contents of design documents in practice, and cultivate enthusiasm for design controls.

Course Content


USA 21 CFR 820.30
ISO 13485:2016, Section 7.3
User needs, design inputs, design planning, design outputs, design verification, design validation, design history file, design transfer, design changes.


Course Features


Focus on design controls, not a general quality management system course
Simplify complex design control regulatory requirements and explain them in plain language
Present design history file (DHF) and device master record (DMR) contents concretely
Use visuals to present each design control activity clearly, making it easy to understand


Course Information


Location: National Yang Ming Chiao Tung University, Yangming Campus, Biomedical Engineering Building, Room 101
Time: December 20 (Monday), 1:30 PM – 4:30 PM