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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.

CER Writing for 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

CER Writing for 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

CER Writing for 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
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