Project Management for EU MDR Deliverables
EU MDR requires a suite of post-market documents for each device in your portfolio: CEP/CER, PMCF-Plan/PMCF-Report, PMS-Plan/PSUR or PMS-Report, SSCP. All documents need to be updated at a set frequency and due dates between deliverables may be linked. Managing schedules of work across large portfolios can be challenging if you do not have the right tools and processes.
Strong project management can help you optimize your work, accurately estimate your resourcing needs, and reduce team stress and turnover.
Project Management Services
Schedule Creation, Optimization, and Maintenance
Create or QC your deliverables schedule(s):
Create a new schedule: for each product in your portfolio, we will determine when each deliverable is due, for which reason, and on which update frequency.
QC an existing schedule: we will cross check alignment of due dates across trackers, ensure no products or deliverables are missing, and ensure update frequencies are correct.
Identify opportunities for consolidation
Propose solutions for level-loading
Create a process for the ongoing maintenance of the schedule and trackers.
Create realistic project plans for various types of projects by with a list of tasks with standard durations and dependencies.
Identify bottlenecks and labor-intensive steps and propose process improvement solutions and efficiency tools.
Create tools for writers to monitor and report progress with ongoing projects.
With a complete schedule and standard project durations, short- and long-term resourcing needs should be assessed.
Short term, 0-12 months: if short term resourcing gaps are identified, reprioritization of projects or vendor support may be needed.
Medium term, 12-24 months: Accurately estimating medium-term staffing needs will give you time to ramp up your team and be ready for the workload.
Long term, 24+ months: Estimating resourcing needs multiple years in advance will help you advocate for adequate long-term budgeting for your team.
We can build complete tracking tools using your preferred project management software. We create sophisticated custom solutions with automated metrics dashboards, projection dashboards, and resourcing Gantt charts.
Why Choose GLOBAL?
Our project managers have scientific backgrounds and extensive experience writing and managing CERs and other MDR deliverables. They will quickly understand your procedures and needs and help build an execution plan with tools that work for you.
We can provide temporary consulting, or we can embed a Project Manager in your team for several months. They will learn your processes, identify your needs, and build a project management structure that fits your team. Once the schedule and processes are built and working, they will transition the maintenance of the tools and schedules to an internal resource on your team.