Medical Device Software Validation

Stand-alone software：

The software is a medical device or its accessory.

Component software：The software is a part of medical device as a component or accessory.

In view of the particularity of software, the manufacturer of medical device software should establish a medical device software lifecycle management procedure conforming to IEC 62304 under the framework of its quality system to ensure safety and effectiveness.

Our Services:

Establish software lifecycle management procedure

Determine the level of the software

Complete software files