摘要
设计开发过程是全面了解医疗器械原理、机理、预期用途、风险分析、工艺技术转化的必须过程。如何对设计开发进行正确的理解,本文从组织机构、设计开发策划、设计开发输入、设计开发输出、设计开发评审、设计开发验证、设计开发确认、设计开发更改八个方面进行了分析。
Design and development process is a comprehensive understanding of medical instrument principle, mechanism, intended use, risk analysis, technology transformation must process. How to make a correct understanding of design and development, starting from the organization, design and development planning, design and development input, design output, design and development review, design and development validation, design and development validation, design and development changes and so on eight aspects are analyzed.
出处
《中国医疗器械信息》
2017年第3期34-37,共4页
China Medical Device Information
关键词
医疗器械生产质量管理规范
设计开发
medical equipment production and the quality control standard, design and development
