The Project: Implement Atlassian JIRA and Confluence While Complying with Key Medical Device Industry Guidelines

Cochlear’s project involved implementing both Atlassian JIRA and Confluence while maintaining corporate compliance with guidelines for the use of computer software in the production of medical systems specified by the Association for the Advancement of Medical Instrumentation (AAMI TIR 36). They needed to document standard procedures and risk analysis and mitigation in order to provide evidence of AAMI compliance in the implementation of the software.

The Solution

Cochlear chose ServiceRocket to assist with the implementation of JIRA and Confluence. Among the deliverables were the following:

• Onsite implementation work to preserve confidentiality and security
• Standard Operating Procedure (SOP) to fulfill basic documentation requirements for the use of JIRA and Confluence
• Risk analysis of the software and recommendations for mitigating risk
• Onsite JIRA and Confluence training to all Cochlear employees in the United States, Europe and Asia Pacific offices
• Sharing of JIRA and Confluence best practices

Cochlear was able to successfully deploy both JIRA and Confluence while also complying with AAMI guidelines for the use of computer software in the production of medical devices.

The Voice of the Customer

Victor Rodrigues, R&D Software Department Manager, Cochlear

“The ServiceRocket guys are fantastic. Not only did they completely fulfill our training needs for Atlassian products, but they also assisted in tackling the challenging task of testing, verifying and documenting the Atlassian products we are using for use in a medical device environment. They did so with enthusiasm and the flexibility required to get the job done so that I can sleep better at night.”

For more information on ServiceRocket’s offerings, please visit the Atlassian Solutions page.