Design and development of medical device products with oocyte collection collector as an example
10.3760/cma.j.cn121382-20240801-00515
- VernacularTitle:以卵母细胞采集仪为例探讨医疗器械产品的设计开发
- Author:
Ying ZHANG
1
;
Hua YIN
;
Jin MA
;
Chunyong YU
Author Information
1. 天津市同业科技发展有限公司，天津 300381
- Keywords:
Medical device;
Oocyte collector;
Design and development
- From:
International Journal of Biomedical Engineering
2024;47(5):513-516
- CountryChina
- Language:Chinese
-
Abstract:
With the increasingly strict regulation of the entire life cycle of medical devices in China, design and development are key processes that affect the quality of medical device products. It is urgent to standardize the design and development process of various medical device enterprises to further reduce the clinical application risks of products. The design and development process of the oocyte collection device was taken as an example, and the design and development activities according to the requirements of quality management system were carried out. The planning, input, output, review, verification, and confirmation process of the product design and development were also analyzed. The designed oocyte collection device meets the design input requirements and can meet the expected clinical use. To carry out design and development activities in accordance with the requirements of the quality management system, and to implement risk management throughout the entire design and development process, in order to design products that meet clinical low risk and are safe and reliable.
