Software Validation for Medical Devices
Course Objective:
- General requirements for Software Validation
- The linkage of the Software Validation with the standards and regulatory requirements
- Step-by-step on performing the Software Validation.
- Hands on experience to develop Software Validation documentation
Duration:
1 daySuitable for:
Any person whom would like to gain the knowledge on the software validation / computer software application validation for medical devices.Contact us for the synopsis.
课程亮点:
- 什么是软件验证?
- 软件验证相关的国际标准和法规要求
- 软件验证的范围包括了什么软件呢?
- 在软件验证当中,我们需要执行IQ/OQ/PQ的方案吗?
- 怎样撰写软件验证的方案呢?
- 实际的练习如何撰写软件验证方案
- 什么时候需要再度执行软件验证呢?
一天
适合人群:
任何想要获取医疗器械软件验证知识的人士。
请联络我们来获取全面的课程资讯。
备注:我们的培训导师可以使用中文来进行培训。
Software Validation for Medical Devices