PV In Medical Device Trials

Pharmacovigilance (PV)

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  • #3810

    Hi all,

    I hope you are all keeping safe and well?

    We are in the process of designing a specific SOP and report form for medical devices. I wondered if anyone had any experience of running device trials and might be happy to share some knowledge and experience with me?  I am trying to adapt our current Safety Reporting SOP and SAE form but I’m not sure this is the best fit.

    Thanks

    Kelly

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