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QA/RA Consulting, Auditing & Training

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Medical Device Non-Product Software Validation

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)

software terms on chalkboard with man in suit looking at it

Jan 12, 2024

Understanding IEC/ISO 62304 and FDA Requirements for Medical Device Software Development Life Cycle (SDLC) Management

Jan 11, 2024

FDA Oversight of AI and Machine-Learning Medical Devices

Jan 11, 2024

EU MDR CER and EU IVDR PER for Software: Understanding MDCG 2020-1

Software as Medical Device

Jan 10, 2024

FDA and EU Risk Requirements for Medical Device Software & SaMD