Pre-Cert Program

The core concept of the Pre-cert Program and AI/ML Framework is still based on the basic principles of medical device regulations, which…

The AI/ML Framework and Pre-Cert Program can be seen as the next generation of FDA regulatory requirements. This article uses a holographic…

Series of studies will be conducted on “The Software Precertification Pilot Program version 1.0 Working Model”, released by FDA, and will…

In this article, the author summarized the Pre-Cert Program in the form of the requirements in the four components. It can be considered…

Organizations that produce safer and more effective device software products not only “do the right things,” but they also “do the things…

SaMD products included in the Pre-Cert Program will be reviewed via risk-based approach such as IMDRF framework. IMDRF framework is based…

The principal objectives of establishing the streamlined premarket review process component of the Software Pre-Cert Program are to…

During the Excellence Appraisal, all organizations would demonstrate the capability to collect and analyze post-launch Real World…