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The purpose of this forum is to provide business decision-makers with changes in regulations and market overviews in major markets such as the United States, the European Union, and China, as a relevant strategy to deal with these market changes.

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