MEDICAL DEVICE REGULATORY CONSULTING MADE SIMPLE
Medical Devices
Navigating the complexities of new medical device regulations, particularly the European Medical
Device Regulation (EU MDR), is a challenging endeavor for manufacturers. GLOBAL offers
comprehensive regulatory writing services tailored to meet these stringent requirements, ensuring seamless compliance and quality submissions.
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.
Partner with GLOBAL for EU MDR Medical Device Writing
Services we offer:
• Clinical Evaluation: CEP, CER
• Post-Market Surveillance: PMS Plan, PMS Report, PSUR
• Post-Market Clinical Follow-up: PMCF Plan, PMCF Report
• Patient and Provider Facing Documents: SSCP, IFU, PIL
• Technical Documentation Compilation
Why Partner with GLOBAL for Medical Device Regulatory Consulting?
End-to-End EU MDR Expertise
GLOBAL provides complete regulatory writing support across every EU MDR requirement, including CEP, CER, PMS, PSUR, PMCF, and SSCPs, ensuring no gaps in compliance.
Tailored, High-Quality Submissions
Each submission is written with precision, aligning with both regulatory expectations and your
device’s unique profile, so you can confidently move through review and approval.
Strategic Partner for Long-Term Compliance
With ongoing support in post-market surveillance, clinical follow-up, and patient-facing documentation, GLOBAL helps you maintain compliance and adapt to evolving EU MDR requirements.