Our customer is one of the world’s leading manufacturers of medical technology devices. With their patented technology, they have set a new level of standards for phaco devices worldwide. Processes that are more stable lead to greater safety and efficiency. This provides more time for the operating surgeons to concentrate on the most important task: the efficient performance of cataract surgery.

Preparation is (almost) everything

Thanks to standardized sprint processes, konplan efficiently implemented changes to the instructions for use which were urgently needed for country approvals. A clear presentation of the affected documents enabled rapid revisions and the bundling of translations which resulted in lower costs.

In close coordination with the customer’s regulatory affairs managers and documentation department, country restrictions could be set and removed again after approval was granted. This ensured smooth and rapid product registrations for the international market.

Real-time transparency with JIRA

Through intensive coordination with project management and a small core team, even urgent changes needed for country registration approvals were accomplished by konplan in one-week sprints and on short notice.
Thanks to the bundling of relevant JIRA tickets and standardized processes from konplan, the international market approvals were efficiently implemented.