EU MDR PMO & Project Delivery

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)