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CER Writing Fee

Medical Device MDR CER Writing Fees

In the global context of CER writing medical device manufacturers and their regulatory teams are currently grappling with a sense of confusion and ambiguity in relation to EU MDR Article 61 and the intricacies of crafting and documenting Clinical Evaluation Reports (CERs) following the guidelines outlined in MEDDEV 2.7/1 Revision 4.

 

Our CER writing consultants and subject matter experts  has invested substantial time and effort in conducting thorough research, which has led to the accumulation of valuable expertise in comprehending the strategies essential for the successful documentation of a clinical evaluation report which satisfies the Notified Body requirements.

 

If your organization has genuine interest in the process of either revising an existing MDD Clinical Evaluation Report or initiating the development of a new one, taking into consideration the regulations specified in Article 61, we kindly request that you examine the pricing information provided below, tailored to your specific device class.

MDR CER Writing for Class Is, Im, Ir & IIa 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

$6000

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

$9000

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

$12000

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

$8000

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

$11000

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

$14000

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

$11000

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

$13000

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

$16000

**Class 1 devices 4500 USD without notified body coordination, PMCF and PSUR