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SoftComply has developed a compliant risk management add-on for Jira, specifically for safety-critical software development. This risk management add-on is configurable to any product risk management method/approach while being fully compliant with the requirements of ISO 14971, the medical device risk management standard.
This add-on provides a familiar tabular view of risk identification, mitigation and verification for full traceability; automatically retrieves the data into initial and residual risk matrices; and automates the generation of the risk reports (needed for audits).
Our team has experience in both regulatory affairs as well as Atlassian development & we aim to help medical device companies get their products to market faster by automating regulatory aspects like risk management.
Many topics regarding regulatory compliance & Atlassian tools have also been addressed in our blog posts.