Follow Us:

EU MDR

Home PMS+PMCF+PSUR+Writing Fees

Quick Contact

    PMS+PMCF+ PSUR+Writing Fees

    We can help you with PMS activities as per MDR Article 83, 84, 85 & 86

     

    ACTIVITY

    CONSULTANT SCOPE OF WORK

    FEES

    INPUTS FROM CLIENT

    PMSData collection and Analysis based on the reactive and proactive sources selected by the manufacturer.

    $ 3000

    40 Days

    • PMS planning
    • PMS period
    • Select the sources from our PMS Plan provided by us.
    • Risk Management File with all residual risks
    • Customer Feed back
    • Sales History and Sales volume data
    • User Feedback in our template.
    • Vigilance and CAPAs if any
    • Reactive source – Clinical Literature Review (CER)

    PMCF study will be decided based on risk and device classification

    Preparation of PMS report with the manufacturer’s support*
    PMCF

    Support in selection of device for PMCF

    $ 2000

    30 days

    • Set PMCF Plan
    • PMCF period selection in line with the PMS
    • Identify List of Study Centers
    • Clinical Investigators
    • Method of PMCF study based on Consultants Inputs
    • Analysis & Conclusion based on the study ( by the evaluator)

    PMCF Evaluation Report

    PSUR

    Benefit-Risk Determination and Conclusion

    $ 3000

    45 days

    • Benefit – Risk determination
    • Information of usage frequency of the device