Clinical Evaluation Procedure and Template

We developed high quality customizable Clinical Evaluation Record mandatory procedures and recommended Forms / Templates in line with MDR article 64 and MEDDEV 2.7/1 Rev 4 in word format.

During the preparation or upgradation of Medical Device Technical File, the Clinical Evaluation Report should be concluded with the help of above supporting documents / record evidences in a structured way.

Clinical Evaluation Report mandatory Procedure / SOP

Clinical Evaluation Plan : 300 USD

Procedure ID : I3C-CER-11/R2-10/19

Identification of Pertinent Data : 150 USD

Procedure ID : I3C-CER-12/R2-10-19

Literature search and Review : 350 USD

Procedure ID : I3C-CER-13/R2-10-19

Appraisal of Clinical Data : 150 USD

Procedure ID : I3C-CER-14/R2-10-19

Demonstration of Equivalence : 150 USD

Procedure ID : I3C-CER-15/R2-10-19

Analysis of Clinical Data : 150 USD

Procedure ID : I3C-CER-16/R2-10-19

Development of Clinical Evaluation Report : 250 USD

Procedure ID : I3C-CER-17/R2-10-19

EN ISO 13485:2016 Clinical Evaluation : 100 USD

Procedure ID : I3C-CER-18/R1-10-19

Clinical Evaluation Report recommended Forms / Template

Clinical Evaluation Plan : 300 USD

Template ID : I3C-TEM-11/R3-10/19

Data retrieved from Manufacturer : 50 USD

Template ID : I3C-TEM-12/R1-10-19

Literature search and Review Plan : 100 USD

Template ID : I3C-TEM-13/R2-10-19

Literature search and Review Report : 150 USD

Template ID : I3C-TEM-14/R2-10-19

Clinical Data Appraisal Plan : 150 USD

Template ID : I3C-TEM-15/R2-10-19

Appraisal of pertinent Data : 100 USD

Template ID : I3C-TEM-16/R2-10-19

Demonstration of Equivalence : 100 USD

Template ID : I3C-TEM-17/R2-10-19

Analysis of Clinical Data : 100 USD

Template ID : I3C-TEM-18/R1-08-19

Clinical Evaluation Report : 450 USD

Template ID : I3C-TEM-19/R3-10-19



Attention!!!

We will be providing the microsoft word file. According to your needs and suitability the word file can be edited and modified before incorporating into ISO 13485 system or in the Technical File / Technical Documentation.

Soon after receipt of payment, a dropbox link will be shared with purchased documents in 1-2 hours. (Dropbox folder will be active for next 6 months with free revision update if so)

In case any delay in receiving the DROPBOX link with word files, please write to enquiry@i3cglobal.com with fund transaction details. immediate action will be taken for sure!

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