Clinical Evaluation Report Documentation Cost


Clinical Evaluation Report Pricing & Cost


Worried or confused about MDR Article 61 or MEDDEV 2.7/1 Revision 4 Clinical Evaluation Report?

No worries. We review your current CER process from top to bottom by our experts. If so, is it really necessary for the makeover to Article 61 we send you a formal offer for your approval. Before we send the offer we take you to the Cockpit and explain what we do and what you must do in due course.

CLINICAL EVALUATION REPORT
www.i3cglobal.com
REGULAR PREMIUM ASSURED
Class III
$7999
Class III
$9999
Class III
$12999
Class IIb
$5999
Class IIb
$6999
Class IIb
$8999
Class IIa
$3999
Class IIa
$4999
Class IIa
$6999
STAGE 0 Development of QMS Clinical Evaluation Process
Scoping for Clinical Evaluation
SOP Development for the Clinical Evaluation Activities
Develop Clinical Evaluation Plan
Guidance and Drafting Declaration of Interest
Clinical Evaluator Profile and Selection Support
STAGE 1 PHASE 1 - Identification of Pertinent Data      
Development of SOP for the Data Retrieval
PHASE 2 - Data Generated and held by Manufacturer *      
Development of SOP for the Literature Search & Review
Identify Literature Source and Scientific Literatures
Search Report
STAGE 2 Development of SOP for the Demonstration of Equivalence
Demonstration for Equivalance Devices
Development of SOP for the Appraisal of Clinical Data
Data Suitability Appraisal
Appraisal of Criteria for Data Contribution
STAGE 3 Development of SOP for Analaysis of the Clinical Data
Analysis of Clinical Data
STAGE 4 Develop Clinical Evaluation Report with Conclusion
Review Risk Management File and do appropriate modification if needed  
Complete documentation and guidance for conducting PMS and also for the PSUR Reporting  
Complete documentation and guidance for conducting PMCF and Reporting  
Review of IFU / User Manual / Pre-Clinical / Bench Test / Performance Test Data  
  Cordination, Answering, making corrections in CER and Resubmission to Notified Body till CER Approval.    

Important:

  • Additional Fess for paid scientific Literatures. The fees may vary between 150-350 USD
  • Complete activities done in cloud. Consultants / Clinical writers travel to client located limited to emergency only.
  • The above fees is for each clinical significance (Clinical Indication) of the medical device.
  • Our practice to complete a Class IIb CER for a clinical indication in less than 120 days.

3 months to 4 months with complete cooperation of the client.

Yes, conclusion and analysis of data from PMS & PMCF needs to be analyzed.

Yes, depending upon the type you selected.

Yes, we provide on additional fees.

No, we do not have the facility.

 

Download CER Fees Chart