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Increased Visibility of Compliance Changes and Automation with RegDesk RIMS Triples Global Submissions and Increases Quality


A 100-year-old medical device company focusing on cardiothoracic devices with offices in 27 nations and operating globally struggled to manage the complexity of having multiple devices in multiple markets. The regulatory team was unable to keep up with the volume of work required to remain current and compliant in an ever-changing environment and avoid human errors from a very manual and cumbersome process. In addition, they struggled to collaborate across business units and track approvals in process.


This medical device company wanted to have visibility into upcoming changes in all countries where they did business and understand how those changes would impact existing products in the field. In addition, they wanted to increase the output and accuracy of the existing team without adding headcount. These objectives were important to them so the company did not experience any lost revenue due to non-compliance.

Why They Chose RegDesk

The company selected RegDesk because of its comprehensive database of regulatory changes by country, its capability to pinpoint products requiring attention, and its ability to automate the submission process workflow. This enhanced visibility would help the team minimize wasted effort, reduce errors, and improve communication across business lines. Additionally, they could apply metrics to track market-level data to identify resources necessary to avoid delays in market access.


The team was able to vastly improve their output and become more accurate in their submissions, which created additional capacity for the team as they moved from being reactive to being proactive in their submission process. Moreover, they achieved improved internal collaboration and streamlined reporting processes. With RegDesk, they were able to substantially elevate both the quality and quantity of their submissions.

Summary of Challenges

  • Increase in the frequency of changes in global markets
  • Lack of visibility into upcoming changes and their impact on existing products
  • Manual process created opportunities for errors and missed deadlines
  • Difficulty collaborating inside the company with key stakeholders due to lack of visibility
  • Missed deadlines resulting in lost revenue
  • Overwhelming volume of work was difficult with the existing team

Summary of Results

  • Doubled the quantity of submissions in every market and tripled the global output in two years with automation while keeping the team the same size
  • Reduced the number of hours per submission by improving accuracy and quality
  • Improved the perception of the department by becoming proactive versus reactive due to insights of upcoming changes and their impact
  • Reduced the number of missed deadlines and loss of revenue 
  • Increased the capacity of the team while reducing the burden on individual team members