• Risk Manager

SoftComply Risk Manager

SoftComply Risk Manager is an add-on for JIRA Cloud to manage, trace and report your product risks. Fully customizable and integrated to Atlassian JIRA Cloud.

SoftComply Risk Manager
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FEATURES:

Customizable

SoftComply Risk Manager is a Risk Analysis add-on that is fully customizable to any risk management method or approach, e.g. FMEA or Hazard Analysis, used in safety-critical product development like medical devices.

 

Integration

SoftComply Risk Manager is fully integrated to Atlassian JIRA.

 

Traceability

SoftComply Risk Manager records links between risks, requirements, test cases and other risks for traceability and audit trails.

 

Reporting

Automated generation of pre-filled and tailorable Risk Reports (Risk Management Plan and Risk Management Report) including the visualization of risks in Initial and Residual Risk Matrices.

 

BENEFITS:

 

Supports FDA and CE-marking

SoftComply Risk Manager is based on ISO 14971:2012; and IEC 62304:2006 thus comprehensively focusing on the EU and USA markets.

 

First Risk Management add-on for JIRA Cloud

SoftComply Risk Manager is the only risk management add-on for JIRA Cloud.

 

Most Competitive Price

Get SoftComply Risk Manager from as low as $35 per month from Atlassian Marketplace.

 

The majority of our clients are from USA, UK, rest of Europe
&
they include startups as well as Fortune 500 companies.

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Want to ask us about the SoftComply Risk Manager?

You can learn more about how to use the SoftComply Risk Manager from the User Guide.