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Future of AI/ML-Based SaMD and the Application
The US medical regulating authority (FDA) finished the discussion on recently published framework for Software as a Medical Device (SaMD) to create a basic guidelines for innovative technologies such as artificial...
Software Pre-certification Pilot Program (Pre-Cert)
Pre-cert Program, or also known as the Software Precertification Pilot Program (Pre-Cert), was first mentioned in the FDA’s Digital Health Innovation Action Plan. The purpose of this pilot program is to create a...
The EMA Published Draft Guidance on DDC Products.
European Medicines Agency issued a new draft guidance related to drug-device combinations. This particular regulation specifies the necessary documents for the application for marketing authorization for these types of...