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Drug, Device, or Both? Overview of FDA Premarket Regulation of Combination Products
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Medical Device & IVD Usability Testing and FDA Human Factors Requirements
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FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD)
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Still Maintaining Duplicate MDD/MDR and IVDD/IVDR Documentation?
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Understanding IEC/ISO 62304 and FDA Requirements for Medical Device Software Development Life Cycle (SDLC) Management
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Which EU Notified Bodies Have Been “Designated” Under the MDR 2017/745 and IVDR 2017/746?
