I3CGlobal Unique Device Identification January 24, 2025 UDI (Unique Device Identification): Ensuring Traceability and Compliance in the EU Market Introduction ... Read More
I3CGlobal FDA, FDA 510k, Medical Device January 24, 2025 Software in a Medical Device Existing Changes: 510k Submission Decision-Making In the rapidly evolving medical device industry, software integration plays a critical role in enhan... Read More
I3CGlobal Clinical Evaluation January 24, 2025 Clinical Evaluation vs Clinical Investigations ... Read More
I3CGlobal FDA, FDA 510k January 24, 2025 MDUFA for FDA 510k Submission (Medical Device User Fee Amendments) ... Read More
I3CGlobal FDA, FDA 510k January 24, 2025 In Vitro Diagnostic Devices: US FDA Regulatory Overview ... Read More
I3CGlobal PMCF, Post Market Surveillance, PSUR January 24, 2025 Post Market Surveillance and PMCF Plan Updates ... Read More
I3CGlobal Clinical Evaluation January 24, 2025 Clinical Evaluation and Labelling: How They are Interlinked ... Read More
I3CGlobal Clinical Evaluation January 24, 2025 Clinical Evaluation Process for Combination Products ... Read More
I3CGlobal Clinical Evaluation January 24, 2025 Technical, Biological, and Clinical Aspects of Demonstrating Equivalence ... Read More
