• Med Device PMCF: How to get right Sample Size

    9 September 2021 PMCF
    Post Marketing Clinical Follow up (PMCF) study is a continuous process that updates the clinical ...
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  •

    EU MDR – Medical Device Labeling Changes & Challenges

    8 September 2021 EU MDR
    Global rollout of EU MDR and other UDI-type of regulations are driving all medical device companies ...
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  •

    Clinical data for MDR/IVDR make it easy with real world Approach

    8 September 2021 EU MDR
    We all know that EU MDR and IVDR are clinical data hungry. When the assessment shows that you need ...
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  •

    Medical Devices – USA/Europe Regulatory Updates round up – Aug 2021

    3 September 2021 Regulatory Updates
    EUROPE | US FDA EUROPE 1. Clarification on “first certification for that type of ...
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  •

    Medical Devices – Asia Regulatory Updates round up – Aug 2021

    2 September 2021 Regulatory Updates
    Philippines (FDA) | India (CDSCO) | Pakistan (DRA) | Bahrain (DRA) | Australia Philippines ...
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  •

    Medical Devices – USA/Europe Regulatory Updates round up – Jul 2021

    3 August 2021 Regulatory Updates
    EUROPE | US FDA | CANADA (HC) EUROPE 1. First references of harmonised European ...
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