EU MDR PMO & Project Delivery

Key Challenges

  • Medical Devices client had the right-level of internal talent, but was overloaded with daily work and EU MDR (2017/745) expectations.
  • Our Project Management team drove the PMO and partnered with the client to successfully deliver the EU MDR project ahead of the newly updated 2021 deadline.

Treximo Solution

  • Conducted planning session(s) 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

Outcome

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