Nov 18, 2025
Understanding FDA’s 2025 Draft Guidance on AI-Enabled Medical Devices
Apr 03, 2025
The EU AI Act and Its Impact on Medical Devices
Feb 24, 2025
Compliance Requirements for Medical Device Software and Software as a Medical Device (SaMD) in the US and EU
Jan 12, 2024
Medical Device Production, QMS and NPS Software Risk Assessment, Validation, and Protocols
Jan 12, 2024
FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD)
Jan 12, 2024
Understanding IEC/ISO 62304 and FDA Requirements for Medical Device Software Development Life Cycle (SDLC) Management
