Meddev 2.7.1 Rev 4. Clinical Evaluation

CER, PMS, PMCF, PSUR customizable documents

Don't reinvent the wheel every time you start something new. Instead, use procedures and forms / templates drafted by experts in the field. On purchase of word files of procedures and templates, customize as per your requirements by just add, remove, or change as you like. The important feature of our templates is it gives guidance on filling the form in critical sections. So work done fast and you will have the new CER completed quarter of the time expected.

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Mode of despatch: Electronic, by Email

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Sl.No.

Document Name

Document Type

Cost

1

 

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

 

Procedure

 

$ 100

2

 

Clinical Evaluation Plan

 

Procedure

 

$ 300

3

 

Clinical Evaluation Plan

 

Template

 

$ 300

4

 

Identification of Pertinent data

 

Procedure

 

$ 150

5

 

Data retrieved from manufacturer

 

Template

 

$ 50

6

 

Literature search and Review

 

Procedure

 

$ 350

7

 

Literature search and Review Plan

 

Template

 

$ 100

8

 

Literature search and Review Report

 

Template

 

$ 150

9

 

Appraisal of Clinical Data

 

Procedure

 

$ 150

10

 

Clinical Data Appraisal Plan

 

Template

 

$ 150

11

 

Appraisal of pertinent Data

 

Template

 

$ 100

12

 

Demonstration of equivalence

 

Procedure

 

$ 100

13

 

Demonstration of equivalence

 

Template

 

$ 100

14

 

Analysis of Clinical Data

 

Procedure

 

$ 150

15

 

Analysis of Clinical Data

 

Template

 

$ 100

16

 

Development of Clinical Evaluation Report

 

Procedure

 

$ 250

17

 

Clinical Evaluation Report

 

Template

 

$ 450

18

 

Post Market Surveillance

 

Procedure

 

$ 200

19

 

PMS Plan

 

Template

 

$ 350

20

 

Data Collection and Analysis

 

Template

 

$ 150

21

 

Sales Data

 

Template

 

$ 50

22

 

PMS Report

 

Template

 

$ 300

23

 

Customer Feedback Form

 

Template

 

$ 50

24

 

User Feedback Form

 

Template

 

$ 50

25

 

PMCF Procedure

 

Procedure

 

$ 200

26

 

PMCF Device Slection

 

Template

 

$ 50

27

 

PMCF Plan

 

Template

 

$ 300

28

 

PMCF Study - Centers

 

Template

 

$ 50

29

 

PMCF - Extended Follow Up of Clinical Investigation

 

Template

 

$ 1000

30

 

PMCF - New Investigation

 

Template

 

$ 850

31

 

PMCF - Device Registry

 

Template

 

$ 850

32

 

PMCF - Retrospective Study

 

Template

 

$ 350

33

 

PMCF Analysis and Conclusion

 

Template

 

$ 350

34

 

PMCF Evaluation Report

 

Template

 

$ 350

35

 

Periodic Safety Update Report

 

Procedure

 

$ 200

36

 

PSUR Register

 

Template

 

$ 50

37

 

PSUR Action Plan & Follow up.

 

Template

 

$ 50

38

 

PSUR Report

 

Template

 

$ 350

 

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