POST-MARKET SUPPORT FROM PMCF REPORTS TO GLOBAL SUBMISSIONS
Project Management
In just the device post-approval space, the EU MDR mandates various post-market documents for each device in your portfolio, including CEP/CER, PMCF Plan/PMCF Report, PMS Plan/PSUR or PMS Report, and SSCP, all requiring regular updates.
And, a typical biological product necessitates over 60 Module-3 Quality sections for just one BLA, and source docs for Module-2 Clinical section can be over 3,000 pages long!
Managing these schedules and deliverables across a large portfolio can be challenging without the right tools and processes. Effective project management can optimize work, accurately estimate resource needs, and reduce team stress and turnover.
Intro to CERs Training Course
This course includes an overview and introduction to the clinical evaluation process. Complete with GLOBAL’s best practices and tips and tricks for success, this essentials course is perfect for getting novice writers on your team up and running. This training course includes:
• Live, online training sessions
discussing CER components and key strategies for success
• Access to recorded training sessions for reference
EU MDR Professional
Mentorship Program
Our professional mentoring program follows GLOBAL’s unique internship structure, customized for your team’s workflows, procedures, and device portfolio. Key aspects of the program include:
• Live, online training sessions with recordings and slide decks
• Practice assignments with answer keys
• Personalized feedback and guidance on the EU MDR documents in your team's pipeline
CER Bootcamp
The CER Bootcamp Course is an intensive training program designed to provide a thorough introduction to the clinical evaluation process. Tailored for novice writers, this course leverages
GLOBAL’s best practices, tips, and tricks to get your team up and running efficiently. Combining live, interactive sessions with comprehensive resources, the bootcamp ensures participants gain
the essential skills needed to produce high-quality Clinical Evaluation Reports CERs).
Train the Trainer Masterclass
The Train the Trainer Masterclass is aspecialized program designed to equip trainers with the skills and knowledge needed to effectively teach and mentor teams in the key deliverables required for EU MDR compliance (CER/CEPs, PMCF Plans/Report, PMCF Plans/Reports, PMSPlan/PSURS and PMS Reports).
Leveraging GLOBAL’s proven methodologies and best practices, this masterclass ensures that trainers are fully prepared to deliver high-quality, impactful training sessions and provide ongoing mentorship.
Custom Training Solutions
At GLOBAL, we understand that each organization has unique needs and challenges. That's why we offer custom training solutions designed to empower your team with the specific knowledge and skills required to write effective and compliant Clinical Evaluation Reports (CERs) and other EU MDR deliverables. Our bespoke training programs are crafted to align with your workflows, procedures, and device portfolio, ensuring immediate and practical application.
Comprehensive Project Management Services
GLOBAL’s project management service offerings include the following:
Schedule Creation, Optimization, and Maintenance
- Create or consult on deliverable schedules
- Schedule optimization and consolidation
- Ongoing schedule maintenance
Project Timelines
• Develop realistic project plans with task lists and dependencies
• Identify bottlenecks and propose efficiency improvements
• Tools for progress monitoring and reporting
Resourcing Projections
• Short-term (0-12 months): Reprioritization or vendor support for gaps
• Medium-term (12-24 months): Ramp-up staffing needs
• Long-term (24+ months): Budget advocacy for long-term needs
Customized Tools
• Build tracking tools in preferred project management software
• Create custom solutions with automated dashboards and Gantt charts
Embedded Project Managers
Why Choose GLOBAL for Project Management?
Anticipate Risks
We know where bottlenecks happen and address them before they cause delays.
Streamline Processes
From resourcing projects to custom tools, we optimize the way your team works.
Support Compliance
Every requirement from PMCF reports to BLAs is managed with precision and accuracy.