
Medical Device MDR CER Writing Fees
Manufacturers 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.
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
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
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
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
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
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
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
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
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
**Class 1 devices 4500 USD without notified body coordination, PMCF and PSUR