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    MDR Technical File Templates

    We have a lot of enquires from website visitors and our old customers requesting us to release Technical Documentation / Technical File MDR complied templates.

    Thanks to the efforts put by our team members to bring up templates very specific to each risk class and category of devices.

    We received 200 plus positive feedbacks about the templates so far after releasing the first version in September 2019.

    Class I Technical File Templates (Including Is / Im / Ir)

    Active Device - Non-Sterile with / without Software

    Pricing : 400 USD

    Document ID : TF-01

    MDR Technical File Templates 1

    Non-Active Device - Non-Sterile

    Pricing : 400 USD

    Document ID : TF-02

    MDR Technical File Templates 1

    Non-Active Device - Sterile / Measuring / Reusable

    Pricing : 500 USD

    Document ID : TF-03

    MDR Technical File Templates 1

    Active Device - Sterile / Measuring / Reusable

    Pricing : 500 USD

    Document ID : TF-04

    MDR Technical File Templates 1

    Software Device with or without Measuring Function

    Pricing : 500 USD

    Document ID : TF-05

    MDR Technical File Templates 1

    Class IIa Technical File Templates

    Active Device - Sterile / Non-Sterile / Measuring / Reusable /with / without Software

    Pricing : 500 USD

    Document ID : TF-06

    MDR Technical File Templates 1

    Non-Active Device - Sterile / Non-Sterile / Measuring / Reusable

    Pricing : 500 USD

    Document ID : TF-07

    MDR Technical File Templates 1

    Non-Active Device - Implant Sterile / Non-Sterile / Measuring / Reusable

    Pricing : 600 USD

    Document ID : TF-08

    MDR Technical File Templates 1

    Software Medical Device with or without Measuring Function

    Pricing : 500 USD

    Document ID : TF-09

    MDR Technical File Templates 1

    Class IIb Technical File Templates

    Active Device - Sterile / Non-Sterile / Measuring / Reusable with/without Software

    Pricing : 600 USD

    Document ID : TF-10

    MDR Technical File Templates 1

    Non-Active Device - Sterile / Non-Sterile / Measuring / Reusable

    Pricing : 600 USD

    Document ID : TF-11

    MDR Technical File Templates 1

    Non-Active Device - Implant - Sterile / Nonsterile / Measuring / Reusable

    Pricing : 700 USD

    Document ID : TF-12

    MDR Technical File Templates 1

    Software Medical Device with or without Measuring Function

    Pricing : 600 USD

    Document ID : TF-13

    MDR Technical File Templates 1

    Class III Technical File Templates

    Active Device - Sterile / Non-Sterile / Measuring / Reusable with/without Software

    Pricing : 700 USD

    Document ID : TF-14

    MDR Technical File Templates 1

    Non-Active Device - Sterile / Non-Sterile / Measuring / Reusable

    Pricing : 700 USD

    Document ID : TF-15

    MDR Technical File Templates 1

    Non-Active Device – Implant - Sterile / Non-Sterile / Measuring / Reusable

    Pricing : 800 USD

    Document ID : TF-16

    MDR Technical File Templates 1

    Active Device - Implant - Sterile / Non-Sterile / Measuring / Reusable / with or without Software

    Pricing : 800 USD

    Document ID : TF-17

    MDR Technical File Templates 1

    Software with or without Measuring Function

    Pricing : 700 USD

    Document ID : TF-18

    MDR Technical File Templates 1

    Special Rule Technical File Templates

    Class III Devices Incorporate Medicinal Product under Rule 14

    Pricing : 900 USD

    Document ID : TF-19

    MDR Technical File Templates 1

    Class IIa/IIb Devices for Contraception under Rule 15

    Pricing : 900 USD

    Document ID : TF-20

    MDR Technical File Templates 1

    Class IIa/IIb Devices used for Disinfecting, Cleaning or Sterilizing Medical Device under Rule 16

    Pricing : 700 USD

    Document ID : TF-21

    MDR Technical File Templates 1

    Class III Devices made using tissues or cells of human or Animal Origin, or their derivatives under Rule 18

    Pricing : 1200 USD

    Document ID : TF-22

    MDR Technical File Templates 1

    Class IIa/ IIb/III Nanomaterials under Rule 19

    Pricing : 1200 USD

    Document ID : TF-23

    MDR Technical File Templates 1

    Class IIa/IIb Devices for Medicinal Inhalation under Rule 20

    Pricing : 700 USD

    Document ID : TF-24

    MDR Technical File Templates 1

    Class IIa/IIb/III Devices composed of substances that are absorbed or locally dispersed under Rule 21

    Pricing : 1100 USD

    Document ID : TF-25

    MDR Technical File Templates 1

    Attention!!!

    The templates developed by our technical experts and are purely based on MDR requirements, but the interpretation of guidelines and structure framed based on our experience and capabilities.

     

    The briefing or explanations given in each section does not constitute an official or signed contract and no complaints entertained. Buyers should understand the authors/developers are human beings and can possibly find few drawbacks when interpreted by Notified Bodies or other technical experts in this field.

     

    But for sure we made tremendous efforts to make it public with the best quality available on the world wideΒ web. All rights reserved by I3CGlobal.

     

    We will NOT refund the amount once the document is sent. The purchased files are NOT Auto downloadable. On receipt of payment intimation, you will receive a link to the email ID provided anytime between 1-6 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.

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