Atlassian JIRA and Confluence at Cochlear
Compliance of software used in the production of medical devices
The Challenge
- Implementation of the Atlassian JIRA and Confluence software products, whilst 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) - Evidence of AAMI compliance in the implementation of JIRA and Confluence (classed as Off-The-Shelf software):
- Documentation of standard procedures
- Risk analysis and mitigation
- General improvement of internal education and training for JIRA and Confluence, leveraging CustomWare's expert knowledge of the products and industry best practices
- Documentation of procedures to be used in the maintenance and administration of JIRA and Confluence
The Solution
- Produced a Standard Operating Procedure (SOP) to fulfill basic documentation requirements for the use of JIRA and Confluence
- Administered a high level risk analysis of JIRA and Confluence
- Submitted recommendations to mitigate risks
- Provided JIRA and Confluence training to employees in US, European and Asia Pacific offices
- Onsite work conducted to preserve confidentiality and security
The Result
- Compliance with AAMI guidelines for use of computer software in the production of medical systems
- Risk mitigation to reduce the likelihood and severity of incidents
- Efficient use of JIRA and Confluence by employees, improving corporate communication systems
The Voice of the Customer
Victor Rodrigues, D&D Software Department Manager, Cochlear
Those Customware guys are fantastic. Not only did they completely fulfil our training needs for Atlassian products but they 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.
The Company
Cochlear is the industry leader in implantable hearing technologies with revenues exceeding $555 million. They have helped over 125,000 people worldwide with their products.
More information
For more information on how CustomWare can help streamline your next Atlassian implementation, please see our Atlassian Solutions page.
