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    Regulatory burden: Impact on developing countries ...

    This message was posted by a user wishing to remain anonymous Hello all! The other day I was asked whether the burden of medical product regulation impacts the developing world disproportionately. Was curious what your thoughts were. It's a complicated ...

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    South Africa Active Med Device - NRCS and ICASA ap ...

    This message was posted by a user wishing to remain anonymous Has anyone successfully launched an active medical device requiring NRCS and ICASA approval? If so, were you able to leverage completed testing to medical safety and electrical standards ...

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    Cybersecurity - HITRUST CSF vs Appendix 1 of FDA G ...

    This message was posted by a user wishing to remain anonymous In Appendix 1 of FDA's Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, FDA lays out requirements across 8 security categories. ...

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    Registration in Ukraine

    This message was posted by a user wishing to remain anonymous Hello all, I would have a question regarding registration of medical devices in Ukraine especially under CE certificate recognition path. Does any of you know if it is mandatory to register ...

  • This message was posted by a user wishing to remain anonymous Hello RAPS Community, I hope that some of you have already made expierence on cybersecurity requirements on portable media and is able to share with the expertise. My questions is the ...

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