Jan 12, 2024
Medical Device Production, QMS and NPS Software Risk Assessment, Validation, and Protocols
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FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD)
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Understanding IEC/ISO 62304 and FDA Requirements for Medical Device Software Development Life Cycle (SDLC) Management
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FDA Oversight of AI and Machine-Learning Medical Devices
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EU MDR CER and EU IVDR PER for Software: Understanding MDCG 2020-1
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FDA and EU Risk Requirements for Medical Device Software & SaMD