This Assistant takes the shape of a Checklist where you assess your own medical device against the OWASP Top 10 security risks.
You start out by assessing whether the risk is applicable to your device at all, and if not, provide a qulified answer why this is not the case (the auditors rewards such qualifications!).
If the risk is applicable, you are required to refer to the Aligned Elements Design Control Items that addresses the risk by selecting them in the UI.
You can compare your risk reduction controls against known best-practice remidiations mentioned in the OWASP Top 10 list.
When the checklist is completed, a Regulatory Assistance item is generated, containing all steps and your provided answers. This information remains stored in Aligned Elements for compliance purposes.
The OWASP Top 10 Regulatory Assistant Checklist is free to all Aligned Elements customers and can be applied to any Aligned Elements Web Server installation.
Note! The OWASP Top 10 Regulatory Assistant Checklist only works in Aligned Elements.
Load this Regulatory Assistant Checklist in Aligned Elements, run it, answer the questions and you will have performed a gap analysis of your current development documentation.
