[Key Points of Design and Risk Analysis in Production for Biodegradable Heart Occluder].

ABSTRACT

Biodegradable heart occluder uses a biodegradable medical polymer material to replace or completely replace the metal material. After completing the repair function of the heart defect, the device is gradually degraded and safely absorbed by the human tissue. So it may minimize the risk of long-term complications that traditional metal heart occluder causing in the body after implantation. Based on the quality management concept of the entire lifecycle of medical device, this article briefly introduces design and development, as well as the product realization of biodegradable heart occluder. It analyzes the main risk points in design and production, and corresponding suggestions have been put forward. These suggestions are combined with the medical device good manufacturing practice and the appendix of implantable medical equipment to provide a reference for regulators and industry professionals.