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Clinical Evaluation Report (CER) Documentation Service Fees

 

Clinical Evaluation Report (CER) Documentation Service Fees

Regular Service

Premium Service

Assured Service

Class 111 $1999

Class 111 $2999

Class 111 $3999

Class 11b $1699

Class 11b $2699

Class 11b $3699

Class 11a $1299

Class 11a $2199

Class 11a $2999

STAGE 0

0.1 Clinical Evaluation Procedure

0.2 Scoping

0.3 SOP for Stages of Clinical Evaluation

0.4 Clinical Evaluation Plan

0.5 Declaration of Interest

0.6 CV of the Evaluator

STAGE 1

Phase 1

 

 

 

1.1 Identification of Pertinent Data

Phase 2

 

 

 

1.2 SOP for Literature Search and Review

1.3 Search Results

1.4 Search Report

STAGE 2

2.1 SOP for Demonstration of Equivalence

2.2 Demonstration of Equivalent Devices

2.3 SOP for Appraisal of Clinical Data

2.4 Data Suitability Appraisal

2.5 Appraisal of Criteria for Data Contribution 

STAGE 3

3.1 SOP for Analysis of the Clinical Data

3.2 Analysis of Clinical Data

STAGE 4

4.1 Clinical Evaluation Report with below supporting evidences

4.1(a) Risk Analysis procedure + Risk Management File

 

4.1(b) Post Market Surveillance (PMS) procedure + Records Templets + PMS Plan + 2017-2018 PMS records

 

4.1(c) Post Market Clinical Follow (PMCF) procedure + Records Templets + 2017-2018 PMCF records (if applicable)

 

4.1(d) IFU

 

Coordination with Notified Body, answering to NB on behalf of clients, Update and resubmit the CER as per review /NC

 

 

 


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