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Clinical Evaluation Report ( SOP & Templates)
We thanks to our Clinical Evaluation team for releasing the procedures and templates to medical device fraternity. Hundreds of companies so far benefited with ready to use and customizable word files we released and open for purchase from September 2019 onwards. Team I3CGLOBAL is very confident the documents sold are inline with MDR article 64 and MEDDEV 2.7/1 Rev. 4.
Customers can think about purchasing the documents during the preparation or up-gradation of MDR Technical Documentation or Clinical Evaluation Report. All templets are reasonable priced and sure for value for money.
Clinical Evaluation Report mandatory Procedure/SOPs
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/Templates
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 |
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The files are NOT Auto downloadable. On receipt of payment intimation you will send a link to the email ID provided. This may happen anytime between 1-5 hours. ( Saturday & Sunday expect more delays)
In case of any delay in receiving the download link, please write to enquiry@i3cglobal.com with fund transaction details. We will take Immediate action to solve your concern!
