ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
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CER, PMS, PMCF, PSUR customizable documents for purchase


Payment Method Paypal / Wire transfer to India

Mode of despatch: Electronic, by Email

Complaints / Delay: write to admin@i3cglobal.com

Item Code

Document Name

Document type

Cost

1

 

Clinical Evaluation(mandatory as per EN ISO 13485:2016)

 

Procedure

 

$ 50

2

 

Clinical Evaluation Plan

 

Procedure

 

$ 300

3

 

Clinical Evaluation Plan

 

Template

 

$ 300

4

 

Identification of Pertinent data

 

Procedure

 

$ 50

5

 

Data retrieved from manufacturer

 

Template

 

$ 50

6

 

Literature search and Review

 

Procedure

 

$ 350

7

 

Literature search and Review Plan

 

Template

 

$ 50

8

 

Literature search and Review Report

 

Template

 

$ 250

9

 

Appraisal of Clinical Data

 

Procedure

 

$ 150

10

 

Appraisal Plan

 

Template

 

$ 50

11

 

Appraisal of pertinent Data

 

Template

 

$ 50

12

 

Demonstration of equivalence

 

Procedure

 

$ 150

13

 

Demonstration of equivalence

 

Template

 

$ 50

14

 

Analysis of Clinical data

 

Procedure

 

$ 50

15

 

Analysis of Clinical Data

 

Template

 

$ 50

16

 

Development of Clinical Evaluation Report

 

Procedure

 

$ 250

17

 

Clinical Evaluation Report

 

Template

 

$ 450

18

 

Post Market Surveillance

 

Procedure

 

$ 50

19

 

PMS Plan

 

Template

 

$ 50

20

 

Sales Data

 

Template

 

$ 50

21

 

PMS Report

 

Template

 

$ 250

22

 

Post Market Clinical Follow Up

 

Procedure

 

$ 50

23

 

Selection of Devices

 

Template

 

$ 50

24

 

PMCF Plan

 

Template

 

$ 450

25

 

PMCF Study - Extended Follow Up

 

Template

 

$ 550

26

 

PMCF Study - Centers

 

Template

 

$ 50

27

 

PMCF Study - New Clinical Investigation

 

Template

 

$ 650

28

 

PMCF Study - Device Registry Data Review

 

Template

 

$ 450

29

 

PMCF Study - Retrospective Clinical Study

 

Template

 

$ 450

30

 

PMCF Analysis and Conclusion

 

Template

 

$ 250

31

 

PMCF Evaluation Report

 

Template

 

$ 250

32

 

Periodic Safety Update Report

 

Procedure

 

$ 450

33

 

PSUR Register

 

Template

 

$ 50

34

 

PSUR Action Plan & Follow up.

 

Template

 

$ 50

35

 

PSUR Report

 

Template

 

$ 450

 

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