Extensions | Aligned Elements - the Medical Device ALM

Johner Institute Medical Device IT Security Product Requirements

The Johner Institute has in collaboration with TÜV SÜD, TÜV Nord and Dr. Heidenreich (Siemens) compiled an excellent set of Medical Device IT Security Process and Product requirements.

The entire guideline is available in the GitHub-Repository „IT Security Guideline“ (https://github.com/johner-institut/it-security-guideline/).

This extension contains the 50 Product IT Security Requirements, which make up the second part of the guideline.

To use the extension, download and unzip the extension file. Place the Cyber Security Requirement.rvt template in the template root folder and the Word Template in the RTFTemplate folder.

Then import the xml file into the project. Make sure the "Recreate Chapters" option is activated when importing the requirements.


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