EU MDR Consulting & Regulatory Writing Services
GLOBAL provides comprehensive EU MDR and CER regulatory consulting and writing services
End-to-End Support for EU MDR Compliance & Submissions
The EU Medical Device Regulation (MDR) significantly raises the bar for clinical evidence, post-market oversight, and documentation structure. Our EU MDR regulatory strategy and writing services ensure you meet these expectations with clarity, consistency, and efficiency.
EU MDR Regulatory Strategy Tailored to Your Needs
At GLOBAL, we deliver customized EU MDR support to help medical device companies achieve and maintain EU MDR compliance. Whether you're launching a new device, updating legacy documentation, or navigating feedback from a Notified Body, our experts provide strategic guidance and high-quality document authoring for all MDR deliverables.
We can help you:
- Conduct gap analyses for your EU MDR documentation
- Compile CERs that integrate clinical, PMS, and PMCF data into a compelling and audit-ready story
- Respond to Notified Body questions and prepare supporting documentation related to your CER and technical file
- Plan and manage CER updates by prioritizing device portfolios based on class, legacy status, and risk
700 + CERs Filed Successfully
35 + Satisfied Clients
23+ Writers and Consultants
Our EU MDR Documentation Services Include:
Define your methodology and clinical evaluation strategy by:
- Determining the clinical evaluation scope, including accessories and devices used in combination
- Developing literature search protocols
- Establishing methodologies for collecting clinical data
- Justifying the clinical evaluation strategy
Our CER authoring services deliver fully MDR-compliant reports, including:
- Defining safety and performance outcomes with acceptance thresholds
- Managing the incorporation and analysis of PMS, PMCF, and other clinical data
- Conducting MDR-compliant systematic literature reviews
- Building strong equivalence arguments with clinical, technical, and biological data
- Evaluating clinical evidence to support GSPR conformance
- Performing device-specific risk-benefit assessments
Post-market Clinical Follow-up services, including:
- Defining endpoints and data collection methods for post-market follow-up
- Developing MDR-compliant PMCF Plans and Reports
- Analyzing and present PMCF data to support ongoing safety and performance evaluation
- Designing PMCF activities aligned with clinical evaluation objectives
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Clear, summaries designed for EUDAMED publication:
- Drafting Class III and implantable device SSCPs
- Reviewing for clarity, scientific accuracy, and relevance to intended audiences
- Establishing appropriate reading levels for clinicians and patients
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Using MDR Annex III, we will develop your PMS Plans and Reports and PSURS to meet Article 86 obligations. Our services include:
- Cumulative benefit-risk evaluations
- Safety signal analysis
- Class I PMS Reports
- Class IIa, IIb, and III submissions
- Periodic Safety Update Reports (PSURs)
- Adaption of EU MDR PSURS for regional submissions - UK PSURs per MHRA, ASRs per Health Canada, etc.
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Our expert team can help you determine the appropriate regulatory and clinical activities to achieve EU MDR compliance:
- Providing guidance on new product development and regulatory strategy
- Conducting clinical and regulatory gap assessments
- Developing standard operating procedures and templates
- Establishing pre- and post-market clinical evidence strategies
- Supporting Notified Body response strategy and execution
- Planning technical documentation remediation efforts
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Organize your portfolio by:
- Creating, optimizing, and maintaining schedules for EU MDR deliverables
- Building and implementing standard project timelines, establishing processes, and mapping dependencies across workstreams
- Determining resource projections for short-, medium-, and long-term planning
- Implementing tracking and projection tools to improve team efficiency
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Our team offer full-scale training programs on every aspect of EU MDR and the clinical evaluation (CEP, CER, PMCF, PSURs, SSCP, etc.).
- Conducting short bootcamp trainings for your team
- Providing medium-term support to inexperienced teams
- Supplying guidance and mentorship on real projects
Read more at our blog!
Expert MDR Consulting for Medical Devices
We support Class I, IIa, IIb, and III devices across all therapeutic areas
We provide regulatory writing support for manufacturers that want to meet notified body expectations in the first round of review. Whether you need help writing a single CER or help managing technical files for your entire portfolio, GLOBAL is here for you.
Check out our webinars covering EU MDR topics!
Why Choose GLOBAL for EU MDR Support?
GLOBAL has a large US based team of EU MDR experts that will customize their services to best fit your needs.
- Proven track record with zero major CER nonconformities
- Experts in EU MDR CER literature review process
- Seamless integration of strategy, writing, and project management
- Flexible engagement models: consulting, staff augmentation, or full outsourcing
- Deep knowledge of clinical, regulatory, and scientific standards
Read more about GLOBAL success stories with EU MDR!
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Frequently Asked Questions About EU MDR
Ready to start?
Let us guide you through best practices for CER development and comprehensive EU MDR documentation services. From end-to-end CER writing services to Notified Body response support, GLOBAL is your trusted partner.
