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    Resources regarding US statutes and regulations

    This message was posted by a user wishing to remain anonymous Colleagues, Does anyone have a recommendation for one or more resources (eg, courses, webinars) that can be used to gain a more comprehensive understanding of US statutes and regulations ...

  • This message was posted by a user wishing to remain anonymous Hi, Can someone share a slide deck for Risk-based Scenario Planning with Time Horizon? TIA

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    PMDA Inspection Including unannounced

    This message was posted by a user wishing to remain anonymous For foreign manufacturers, does PMDA conduct unannounced inspections?  For new device registration (Shonin), does PMDA conduct a pre-market approval inspection or will they accept the MDSAP ...

  • This message was posted by a user wishing to remain anonymous Hello,  I would appreciate feedback as to whether allowing compatibility between two licensed knee systems would required a significant amendment to be submitted to Health Canada. There ...

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    adding instrument with a cleared IVD

    This message was posted by a user wishing to remain anonymous Hi, If I have an IVD assay that went thorough the 510k process and got cleared with general instrument. What are the requirements if I need to tie it to a certain instrument? What are all ...

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