EUROPEAN MEDICAL DEVICE REGULATION CONSULTING
EU MDR Consulting Services
Navigating the complex landscape of medical device regulations can be a daunting task for manufacturers, particularly with the stringent requirements of the European Union Medical Device Regulation (EUMDR). The EU MDR has significantly raised the bar compared to previous directives. GLOBAL can help you seamlessly adapt to these new regulations and other regulations in the medical device space.
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.
European Medical Device Regulation Services
Our consulting services include the following:
- Notified Body Response Strategy and Execution
- EU MDR Gap Assessments
- EU MDR Procedures and Templates
- EU MDR Compliant Labeling
- MDR Document Remediation Plans and Schedules
- EU MDR Education and Training
- Clinical Evidence Strategy
- PMCF Strategy
- Clinical Development Planning and Strategy
- FDA Regulatory Strategy and Submissions
EU MDR Expertise
Our core consulting services for European Medical Device Regulation help you navigate complex requirements with confidence, from strategic planning to compliant documentation.
• Notified Body Response Strategy
• Gap Analysis
• Clinical Evidence Strategy
• EU MDR_compliant Procedures and Templates
Expert Guidance to Streamline EU MDR Compliance
Successfully navigating European Medical Device Regulation requires more than just knowledge of the standards; it demands strategic insight, proven processes, and an understanding of how regulators think. At GLOBAL, we combine deep industry expertise with a collaborative approach to help you meet EU MDR requirements efficiently and effectively. From interpreting regulatory changes to developing compliant documentation, we ensure your path to market remains clear, timely, and aligned with your business goals.