Case Study: Cochlear achieves AAMI‑compliant Jira and Confluence deployment for medical devices with ServiceRocket

Implementing Atlassian Jira and Confluence with Tight Regulations

Cochlear, a global leader in implantable hearing technologies that has helped over 250,000 people, needed to implement Atlassian Jira and Confluence across its R&D organization while meeting strict medical-device software guidance (AAMI TIR 36). The challenge included documenting standard procedures, performing risk analysis, and providing verifiable evidence of compliance for software used in the production of medical systems.

ServiceRocket delivered onsite Atlassian consulting to preserve confidentiality, created Standard Operating Procedures, completed risk analysis with mitigation recommendations, and provided JIRA and Confluence training and best-practice guidance across the US, Europe and Asia Pacific. As a result, Cochlear successfully deployed Jira and Confluence in a manner that met AAMI requirements and gave the R&D team confidence in the validated use of the tools.

Cochlear

Victor Rodrigues

Chief Software Engineer