Risk Manager FAQ

There could be several reasons for this. Please have a look at your SoftComply Risk Manager configuration and answer the following questions here.

This is a feature of the SoftComply Risk Manager app that is related to the requirement of ISO 14971 for medical device risk management. To learn more about it and how to disable this option, please continue reading here.

For more information about why you may be seeing empty risk rows in the risk management table and how to avoid it, please continue reading here.

Please read the Security and Permissions related questions and answers at the Risk Manager Security post.

There are a few differences between the Risk Manager and the Risk Manager Plus apps:

• For Data Center Risk Manager apps comparison, please continue here to read all about them.
• For Cloud Risk Manager apps comparison, please continue here.

For more information about accessing your risk data when your app evaluation period ends, please continue reading here.

After installing the SoftComply Risk Manager app in your Jira Server or Jira Data Center, the app will create new custom fields in your Jira. Sometimes you may already have fields with the same names and may want to rename the new fields that were created. Please continue here to learn how you can rename the locked Risk Manager fields.

For information about how data is secured, the security accreditations we hold and how has the app security been assessed, please read on about the Data Security of the SoftComply Risk Manager in our Knowledge Base.