Clinical Evaluation Report Documentation Cost


Clinical Evaluation Report Writer (CER Writing Services)

(Clinical Evaluation Report Writer, Consulting, Document & writing with PMS, PMCF, PSUR)

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

No worries. We review your current clinical evaluation report, CER writing process from top to bottom by our expert writers.

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 REGULAR PREMIUM ASSURED
Class III
$9999
Class III
$11999
Class III
$14999
Class IIb
$6999
Class IIb
$9999
Class IIb
$12999
Class IIa
$4999
Class IIa
$7999
Class IIa
$10999
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 Benefit, IFU / User Manual, Pre-Clinical, Bench Test & Performance Test Data and make appropriate modification if needed  
PMS Guidance & Documentation  
PMCF Guidance and Documentation  
PSUR Guidance & Documentation  
  Cordination, Answering, making corrections in CER and Resubmission to Notified Body till CER Approval.    

Important:

  • Avaliablity of equivalent device 25% fees discount
  • Drug Device combination products 40% additional fees
  • Active Implantable Device 40% additional fees
  • 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.
  • We practice to complete a Class IIb CER writing for a single clinical indication in less than 120 days.

 

Download CER Fees Chart


Client Testimonials...


CER writing Commended by Mr. John on . Best Writers for CER work !!!. and clinical evaluation report. Always provide the quality work under deadline. Rating: 4.9