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EU MDR PMO & Project Delivery

The Challenge 

Medical Devices client had the right level of internal talent but was overloaded with daily work and EU MDR (2017/745) expectations

The Solution 

We provided the client with Project Managers to drive the PMO and deliver the EU MDR project ahead of the newly updated 2021 deadline.

These Project Managers:

  • Conducted planning sessions to define program approach, workstreams, definition of done scope, and timing
  • Designed/rolled-out Program Mgmt structure
  • Built value proposition to educate on importance of regulation, key messages, and potential impacts (e.g. revenue, process, organizational)
  • Developed/executed ongoing governance strategy (Steering Committee, Core, and Extended Teams)
  • Drove project workstreams and developed content with the clients; escalated/resolved issues and risks
  • Defined/rolled-out ongoing communications strategy

The Results 

Planet Pharma helped the client:

  • Create and launch EU MDR PMO and governance structure
  • Complete and communicate EU MDR value proposition to key senior leadership stakeholders (e.g., Manufacturing, Manufacturing QA, R&D QA, PV, Clinical Development)
  • Complete QMS, PMS, and Clinical Documentation Creation and Updates
  • Complete all product remediation activities (e.g., labeling, IFUs, create MDR Tech File)
  • Complete supporting white papers and EU MDR interpretation documentation, including legal reviews
  • Finalize owners for new roles and responsibilities (e.g., PRRC)