On September 2, 2021, the two-day "QSR 820 System and 510K Registration Special Training in the United States" organized by the Shenzhen Medical Device Quality Management Promotion Association came to a successful conclusion at the Mindray Company Lecture Hall.
This special training is jointly organized by the Shenzhen Medical Device Quality Management Promotion Association and Shenzhen Ruinni Medical Device Management Consulting Co., Ltd., with Wang Hailong, General Manager of Ruinni, as the keynote speaker!
With the continuous development and growth of China's medical device industry, it is imperative for medical device enterprises to go abroad and their products to enter the global market. The United States is one of the major markets for medical device products, and the FDA is an experienced regulatory agency for medical device supervision. Its regulatory system also has very strict and detailed requirements. To assist medical device companies intending to expand into the US market and obtain permits for their medical device products to be sold in the US, the Promotion Association has hired industry experts with years of experience in FDA factory inspection cases, FDA 510K registration, and enterprise registration and listing cases to teach QSR 820 system establishment and effective operation, as well as 510K registration knowledge. The aim is to help medical device companies improve the success rate of FDA registration for their medical device products and the standardized operation of their quality management systems.
The training content is rich, practical, and targeted, mainly including: FDA medical device regulatory system, differences between 21 CFR 820 and ISO 13485, FDA factory inspection, 21 CFR QSR 820 quality system regulations, 21 CFR 801 labeling, 21 CFR 807 enterprise registration and product listing for medical device manufacturers and importers, 21 CFR 830 UDI, 21 CFR 860 medical device classification program, 510K registration, etc.
This training has received strong support from the president unit, Shenzhen Mindray Biomedical Electronics Co., Ltd! With a heart of gratitude and feedback, the Promotion Association cordially invites more than 60 member companies who have accompanied and supported the growth of the Promotion Association for more than 5 years to participate in free training. Participants in the training will wear masks and sit separately according to epidemic prevention and control requirements. During the training process, interactive Q&A sessions were held, and the students actively consulted with the teacher regarding the QSR820 quality management system and 510K registration issues. The teacher provided answers one by one, and the students showed a strong interest in the content of this special training and highly praised their learning.
