Ensuring HIPAA Compliance and Cybersecurity for Software as Medical Devices […] Ensuring HIPAA Compliance and Cybersecurity for Software as Medical Devices Read More »
What Notified Bodies Look for in EU MDR Technical Documentation What Notified Bodies Look for in EU MDR Technical Documentation Read More »
Navigating the Medical Device Market Entry Gameplan: The EU and The US Analysis Navigating the Medical Device Market Entry Gameplan: The EU and The US Analysis Read More »
Parliamentary Panel Asks the Government to Notify More Bodies for Audit and Inspection of Medical Device Units Parliamentary Panel Asks the Government to Notify More Bodies for Audit and Inspection of Medical Device Units Read More »
EU MDR Cybersecurity Requirements for Medical Devices EU MDR Cybersecurity Requirements for Medical Devices Read More »
Understanding SaMD and SiMD in Medical Device Regulation Understanding SaMD and SiMD in Medical Device Regulation Read More »
CDSCO Issued Regulatory Guidelines for Sampling of Medical Devices, Drugs and Cosmetics CDSCO Issued Regulatory Guidelines for Sampling of Medical Devices, Drugs and Cosmetics Read More »
Impact of Generative AI in Healthcare: Navigating Regulatory Requirements for Medical Devices Impact of Generative AI in Healthcare: Navigating Regulatory Requirements for Medical Devices Read More »
Guide to Navigating US FDA 510(k) Approval for IVDs (In Vitro Diagnostic Devices) Guide to Navigating US FDA 510(k) Approval for IVDs (In Vitro Diagnostic Devices) Read More »
Indian Government Launches Online Application System for Neutral Code for Medical Device Export Licenses Indian Government Launches Online Application System for Neutral Code for Medical Device Export Licenses Read More »