Follow Us:

ISO 14971

Home Risk Analysis Template & Procedure

Risk Analysis Template & Procedure

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


We will be providing the Microsoft word file. Soon after purchase a DROPBOX link will be send with documents. The folder with purchased 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 with fund transaction ID. We will take action soon for sure!

PMCF Plan Template
Quick Contact