IVDR Celebration Week - What is a clinical performance study, and why do you need it?

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  • เผยแพร่เมื่อ 4 ส.ค. 2024
  • The end goal of a diagnostic device is to diagnose and test the symptoms of the end-user, but what comes before that is all about the production process and various testing requirements.
    One critical requirement is to fulfil a Clinical Performance Study. Interact LIVE with Nicola Wall - CEO - Afortiori Development, who will appraise the facts related to the Clinical Performance Study. Also, Greer Deal - Director - Global Regulatory Services (GRS) - shall complement this session with essential information related to a company’s Quality Management System (QMS) and how this supports clinical activities.
    See you on Thursday 28th April 2022 @ 11:00 AM BST
    Have any questions?
    Drop us an email: mdd@mddltd.com
    Regulation - Our Passion, Your Innovation.
    #IVDRReady
    #RegulatoryCompliance #EUAR #PRRC #USFDA #MDR #IVDR #MedicalDevices #Diagnostics #DigitalHealth #EUAuthorisedRepresentative #ClinicalTrials #Innovation #HealthTech #ClinicalEvaluation #UDI #SaMD
    #PersonResponsibleForRegulatoryCompliance #CyberSecurity #RegulatoryAffairs #MDCG
    #IVDRCelebrationWeek
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