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Risk Analysis Procedure & Template
We have developed a Medical Device ISO 14971 Risk Analysis Procedures and Template in line with MDR & IVDR. 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 conclusions.
Risk Management File (RMF) Procedure / SOP
Risk Managemenet : 200 USD Procedure ID : I3C-RMF-01/R4-11/19 | |
Usablity Engineering : 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 Management 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.
- Identification of Medical Device Characteristics that could have impact on safety.
- Risk Management Plan.
- Risk Management Process.
- Risk Management Report.
