Explic8 Consultants Help Medical Device Company to Implement EU MDR Programme in Record Time

The Ask:

A global medical devices company wanted to embark on the implementation of the EU MDR

Scale:

  • 250+ Technical Files
  • Seven global locations

Challenges:

  • Very little internal experience in large scale program management
  • The organization did not have the experience to bring a global program of this scale through the required phases and into execution
  • A toolkit to address a program of this scale
  • To move a program of this scale required a distinct set of tools that were standardized, scalable and transparent
  • How to measure & track progress over the program lifecycle? (4 Years)
  • Overloaded Internal Staff: How can we make this management as hands free as possible?

Implication

  • EU MDR will be legally binding
  • Products not compliant to EU MDR will no longer saleable in the European Union
  • Annual sales in excess of $300 Million at risk
  • Significant hit to the global organization bottom line

Objective

  • Traceability from the project team scope to the EU MDR Regulation
  • Governance model & program structure standardised & scalable across seven global sites
  • Reduce the management burden of the program as internal staff are heavily loaded
  • Capability for live accurate transparent measurement of progress
  • Bring the program to stable execution before transition
  • Transition: Hand over the management of the program to the internal team

The Approach:

eu mdr case study

Toolkit

  • Explic8 EU MDR Gap Assessment Template
  • Explic8 Work Breakdown Structure Template
  • Explic8 EU MDR Status Report
  • Explic8 EU MDR Progress & Compliance Tracking Database

Results and Benefits

  • Project teams traceable to the EU MDR 2017/745 - MDR "To Do" list
  • Easy, live tracking and management of the Global EU MDR program
  • Global EU MDR program successfully moved to stable execution
  • 87 Project teams initiated, planned, and moved into successful execution
  • 233 Project team members engaged and mobilised
  • Standardised toolkit utilised & knowledge sharing leading to reduced planning phase
  • Global governance structure & communication plan Implemented
  • Graphical toolkit utilised to facilitate remote & group collaboration
  • 8 Months - Start to execution phase for 87 project teams