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    CER Writing Fees

    Manufactures and their Regulatory teams across the globe are confused and figures crossed on MDR Article 61 and MEDDEV 2.7/1 Revision 4 Clinical Evaluation Report CER Writing, and documentation.

     

    We have done extensive research and practically gained sufficient expertise in how, when, and what strategies to be established to successfully conclude a clinical evaluation report. If you are really interested in existing CER makeover or new CER development according to Article 61, have a look at pricing below for the respective class.

    Class I, Is, Im, Ir & IIa Medical Devices

    REGULAR

    • Guidance
    • Development of Procedures & Templates
    • Scoping
    • Clinical Evaluation Planning
    • Identify Literature Source and Scientific Literature
    • Literature Search Report
    • Demonstration for Equivalence Devices
    • Data Suitability Appraisal
    • Appraisal of Criteria for Data Contribution
    • Analysis of Clinical Data
    • Clinical Evaluation Report with Conclusion

    $5000

    PREMIUM

    • Guidance
    • Development of Procedures & Templates
    • Scoping
    • Clinical Evaluation Planning
    • Identify Literature Source and Scientific Literatures
    • Literature Search Report
    • Demonstration for Equivalance Devices
    • Data Suitability Appraisal
    • Appraisal of Criteria for Data Contribution
    • Analysis of Clinical Data
    • Clinical Evaluation Report with Conclusion
    • Review Risk Benefit
    • Review of IFU / User Manual
    • PMS, PMCF & PSUR documentation & support

    $8000

    ASSURED

    • Guidance
    • Development of Procedures & Templates
    • Scoping
    • Clinical Evaluation Planning
    • Identify Literature Source and Scientific Literatures
    • Literature Search Report
    • Demonstration for Equivalance Devices
    • Data Suitability Appraisal
    • Appraisal of Criteria for Data Contribution
    • Analysis of Clinical Data
    • Clinical Evaluation Report with Conclusion
    • Review Risk Benefit
    • Review of IFU / User Manual
    • PMS, PMCF & PSUR documentation & support
    • Answering to Notified Body review comments till acceptance

    $11000

    Class IIb Medical Devices

    REGULAR

    • Guidance
    • Development of Procedures & Templates
    • Scoping
    • Clinical Evaluation Planning
    • Identify Literature Source and Scientific Literatures
    • Literature Search Report
    • Demonstration for Equivalance Devices
    • Data Suitability Appraisal
    • Appraisal of Criteria for Data Contribution
    • Analysis of Clinical Data
    • Clinical Evaluation Report with Conclusion

    $7000

    PREMIUM

    • Guidance
    • Development of Procedures & Templates
    • Scoping
    • Clinical Evaluation Planning
    • Identify Literature Source and Scientific Literatures
    • Literature Search Report
    • Demonstration for Equivalance Devices
    • Data Suitability Appraisal
    • Appraisal of Criteria for Data Contribution
    • Analysis of Clinical Data
    • Clinical Evaluation Report with Conclusion
    • Review Risk Benefit
    • Review of IFU / User Manual
    • PMS, PMCF & PSUR documentation & support

    $10000

    ASSURED

    • Guidance
    • Development of Procedures & Templates
    • Scoping
    • Clinical Evaluation Planning
    • Identify Literature Source and Scientific Literatures
    • Literature Search Report
    • Demonstration for Equivalance Devices
    • Data Suitability Appraisal
    • Appraisal of Criteria for Data Contribution
    • Analysis of Clinical Data
    • Clinical Evaluation Report with Conclusion
    • Review Risk Benefit
    • Review of IFU / User Manual
    • PMS, PMCF & PSUR documentation & support
    • Answering to Notified Body review comments till acceptance

    $13000

    Class III Medical Devices

    REGULAR

    • Guidance
    • Development of Procedures & Templates
    • Scoping
    • Clinical Evaluation Planning
    • Identify Literature Source and Scientific Literatures
    • Literature Search Report
    • Demonstration for Equivalance Devices
    • Data Suitability Appraisal
    • Appraisal of Criteria for Data Contribution
    • Analysis of Clinical Data
    • Clinical Evaluation Report with Conclusion

    $10000

    PREMIUM

    • Guidance
    • Development of Procedures & Templates
    • Scoping
    • Clinical Evaluation Planning
    • Identify Literature Source and Scientific Literatures
    • Literature Search Report
    • Demonstration for Equivalance Devices
    • Data Suitability Appraisal
    • Appraisal of Criteria for Data Contribution
    • Analysis of Clinical Data
    • Clinical Evaluation Report with Conclusion
    • Review Risk Benefit
    • Review of IFU / User Manual
    • PMS, PMCF & PSUR documentation & support

    $12000

    ASSURED

    • Guidance
    • Development of Procedures & Templates
    • Scoping
    • Clinical Evaluation Planning
    • Identify Literature Source and Scientific Literatures
    • Literature Search Report
    • Demonstration for Equivalance Devices
    • Data Suitability Appraisal
    • Appraisal of Criteria for Data Contribution
    • Analysis of Clinical Data
    • Clinical Evaluation Report with Conclusion
    • Review Risk Benefit
    • Review of IFU / User Manual
    • PMS, PMCF & PSUR documentation & support
    • Answering to Notified Body review comments till acceptance

    $15000