Case Study: Crystal Lean Solutions Works with Medical Device Manufacturer to Implement EU Medical Device Regulations
Crystal Lean Solutions (CLS) was approached in late 2019 to provide project management support for the implementation of the EU Medical Device Regulations (EUMDR). The client required assistance in managing the volume of work involved in updating documentation to demonstrate compliance with the new regulations. This case study describes how CLS used an Agile-Scrum approach to manage the project, address challenges, and achieve success for the client.
The EUMDR project was a global initiative that required updating documentation for more than 100 products at client manufacturing sites around the world. CLS was tasked with managing the full reporting structure, identifying workstreams for each product, and coordinating teams to complete tasks within a tight timeframe at the Irish site. The initial deadline was set for 2024, but the amount of work required for each product made it clear that this was a stretch target.
Challenges of a Pandemic Environment
The COVID-19 pandemic further exacerbated the project’s challenges when all personnel involved in the EUMDR project were required to work remotely. This made balancing the workload and priorities of the large and busy team more challenging, with CLS spending 6-7 hours on online meetings every day. The project’s complexity required a lot of coordination, communication, and support to ensure that all deadlines were met.
CLS used an Agile-Scrum approach to manage the project effectively. The approach involved identifying workstreams for each product, estimating timelines for each task, and assigning teams responsible for completing them. Daily Scrum meetings were held across all teams, with Sprint planning and reviews scheduled every two weeks.
The Agile-Scrum approach helped to maintain a clear view of task requirements and which teams were working on what tasks at any given moment. It enabled the project team to adhere to the schedule, even when there were enforced changes to the product submission sequence. The approach provided the flexibility required to manage the project in a changing environment.
During CLS’s time on the EUMDR project, all the deadlines for individual project submissions to the Notified Body were met according to the agreed schedule. The Agile-Scrum approach used helped to manage the project’s complexity, enabled effective communication and collaboration across teams, and ensured that all tasks were completed within the tight timeframe.
The project’s success demonstrated CLS’s ability to provide effective project management support. It also highlighted the benefits of using Agile-Scrum methodologies to manage complex projects with changing requirements and tight deadlines.
The EUMDR project was a significant undertaking for the client, requiring the coordination of multiple teams across global manufacturing sites. CLS provided the necessary project management support to ensure that all deadlines were met, and the project was completed successfully. The Agile-Scrum approach used helped to manage the project’s complexity, maintain effective communication, and ensure that all tasks were completed on time. The success of the project demonstrated the benefits of using Agile-Scrum methodologies for managing complex projects.
For more information or support with your Last Planner® System deployment, Contact us HERE