FDA Guidance on AI-Enabled Device Software – Life Cycle and Market Submission
In January 2025, the U.S. Food and Drug Administration (FDA) relea...
Regulatory Compliance Guide for SSCP Professionals
Summary of Safety and Clinical Performance (SSCP) is a new Regulat...
Clinical Evaluation without Clinical Data in the EU
Application of EU MDR Article 61(10) When Clinical Data is Conside...
US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI Rule on Septemb...
Clinical Data Usage for Medical Device Submissions in EU and US
Clinical Data for Medical Device Submissions in EU
Clinical data f...
Requirements of SSCP (Summary of Safety and Clinical Performance)
What is SSCP? The SSCP (Summary of Safety and Clinical Performance...
