Risk management Procedure and Report

ISO 14971 Risk Management Procedure & Report

We have developed procedure in line with EN ISO 14971 latest harmonized standard. During the preparation of Medical Device CE Marking Technical File, Risk Benefit Analysis is an integral part of compliance documentation along with supporting documents and final risk conclusion.

Risk Management File (RMF) Procedure / SOP

Risk Managemenet Procedure: 200 USD

Procedure ID : I3C-RMF-01/R4-11/19

Usablity Engineering Procedure: 150 USD

Procedure ID : I3C-UEF-01/R3-11/19

Risk Management File (RMF) Forms / Templates

Risk Management File : 350 USD

Template ID: I3C-TEM-50/R2-10/19

Annex A Identification of Medical Device Characteristics : 50 USD

Template ID: I3C-TEM-51/R1-08/19

Annex B Risk Management Plan : 150 USD

Template ID: I3C-TEM-52/R2-10/19

Annex C Risk Management Process : 100 USD

Template ID: I3C-TEM-53/R2-10/19

Annex D Risk Managent Report : 200 USD

Template ID: I3C-TEM-54/R1-10/19

Usability Engineering File : 250 USD

Template ID: I3C-TEM-55/R1-10/19

Attention!!!

We will be providing the microsoft word file. Soon after purchase a DROPBOX link will be send with documents. The folder with purchesd files with revision number will be active for six months. Any revision updates in future will auto updated.

Any delay in receiving the files, please write to enquiry@i3cglobal.com with fund transaction ID. We will take action soon for sure!

Customization will be done in 3 to 4 working days for an additional fees on the following files.

  1. Identification of Medical Device Characteristics that could have impact on safety.
  2. Risk Management Plan.
  3. Risk Management Process.
  4. Risk Management Report.

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