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