Scalability
From a single review to global submission support, we scale effortlessly to meet your project needs.
Clinical Evaluation Report Writing
Expertly Written. Regulatory Ready.
EU MDR–compliant Clinical Evaluation Reports developed by experienced regulatory and clinical writers. We deliver comprehensive clinical data evaluation, systematic literature reviews, and structured benefit–risk analyses designed to support notified body review. Not sure if you’re ready to submit? Download our CER Readiness Checklist.
What We Do: Comprehensive Clinical Evaluation Report (CER) Support
Criterion Edge offers specialized support across the entire CER lifecycle, from clinical evidence strategy and literature evaluation to benefit-risk analysis and notified body submission support. Our services are aligned with EU MDR requirements and applicable guidance to support robust, defensible clinical evaluations.
CER Strategy & Planning
- EU MDR-aligned compliance and readiness assessments
- Equivalence determination and justification
- State-of-the-art analysis
- Clinical evidence strategy and gap analysis
- Evidence planning and clinical development plan support
- Clinical Evaluation Plan (CEP) development and updates
CER Authoring & Documentation
- Full CER development in accordance with MEDDEV 2.7/1 Rev.4
- Device description and intended purpose development
- Benefit-risk analysis and conclusions
- Preclinical and clinical data summaries
- Summary of Safety and Clinical Performance (SSCP) development
Systematic Literature Review Support
- CER-focused literature search strategy development
- Systematic database searches and documentation
- Application of predefined inclusion and exclusion criteria
- Critical appraisal of clinical relevance and quality
- Traceable reporting of methods and results
Clinical Data & Evidence Synthesis
- Integration of clinical, PMCF, and post-market data
- Structured appraisal of safety and performance evidence
- State of the art analysis within current clinical practice
- Benefit-risk analysis aligned with Annex XIV expectations
- Clear evidence synthesis with traceable tables
Quality & Compliance Review
- Internal quality, consistency, and traceability reviews
- Verification of alignment with EU MDR Article 61 requirements
- Review against applicable MEDDEV guidance and Annex XIV alignment
- Final CER readiness and submission review
- Cross-check of evidence tables, references, and source documentation
Regulatory & Lifecycle Support
- Regulatory review support aligned with notified body expectations
- Preparation of written responses to notified body questions
- CER updates and periodic review support
- PMCF plan and PMCF Evaluation Report development
- Ongoing clinical evidence documentation across the device lifecycle
How We Work
Our Proven 5-Step CER Workflow
We deliver efficient, EU MDR-compliant Clinical Evaluation Reports through a transparent, collaborative process designed to satisfy notified body expectations.
1
Strategic Scoping & Regulatory Alignment
We align early on device classification, intended purpose, equivalence approach, and clinical evidence requirements to establish a clear, defensible path to EU MDR alignment. This is captured in your Clinical Evaluation Plan (CEP), which guides the evaluation that follows.
Clinical Evidence & Literature Review
We conduct comprehensive systematic literature reviews and assess all available clinical data including pre-clinical studies, clinical investigations, PMCF data, and vigilance information to build a robust evidence base.
2
3
Data Appraisal & Benefit-Risk Analysis
We critically appraise all clinical data sources, establish state of the art benchmarks, and develop structured benefit-risk analyses aligned with MEDDEV 2.7/1 Rev.4 expectations.
CER Development & Quality Review
We develop a comprehensive CER per Annex XIV requirements, applying rigorous quality, consistency, and traceability reviews to ensure clarity and regulatory defensibility.
4
5
Regulatory Review & Lifecycle Support
We support regulatory review readiness through final CER package preparation, written response development for regulatory questions, and ongoing CER updates across the device lifecycle.
Clinical Evaluation Report Support
Criterion Edge provides strategic, EU MDR-aligned CER support for medical device manufacturers. Our approach combines regulatory expertise, scientific rigor, and clear documentation to support robust clinical evaluations and informed regulatory review.
Dedicated Clinical Evaluation Experts
Clients are supported by experienced CER writers who lead equivalence assessments, literature review strategy, and benefit-risk analysis, ensuring a focused, defensible approach tailored to each device and its clinical context.
Integrated Authoring Across CER Sections
We develop and integrate clinical evidence, literature analysis, and benefit-risk conclusions per MEDDEV 2.7/1 Rev.4 and Annex XIV requirements, ensuring consistency across device description, state of the art analysis, and clinical data appraisal.
Predictable, High-Quality Execution
Our team synthesizes clinical data, literature findings, and post-market evidence into clear, well-structured CER content, supported by structured quality and consistency reviews to support regulatory review readiness.
Turning Clinical Evidence into Regulatory Documentation
We translate complex clinical data into clear, defensible regulatory narratives that support the demonstration of safety and performance and inform benefit-risk conclusions across the device lifecycle.
Are You Ready for a Clinical Evaluation Report?
From initial CE marking through periodic updates and PMCF integration, Criterion Edge supports the development of EU MDR-compliant CERs that demonstrate clinical safety and performance and support regulatory review in Europe.
Am I ready for an CER?
- Download our CER Readiness Checklist to assess clinical evidence and regulatory preparedness
- Confirm device description, intended purpose, and classification are finalized
- Identify gaps in clinical data, literature evidence, or PMCF documentation
When do I need a CER?
- MDD to MDR Transition: Legacy devices must update CERs to meet new EU MDR requirements
- Initial CE Marking: Required for all medical devices seeking EU market access under MDR
- Periodic Updates: CERs must be maintained and updated based on device class, PMCF findings, or significant changes
What is a CER used for?
- Support the demonstration of clinical safety and performance
- Inform benefit-risk determination in accordance with MEDDEV 2.7/1 Rev.4
- Address EU MDR Article 61 and Annex XIV clinical evidence requirements
A Team of experts at your service
Quality Assurance
Quality Assurance Manager
Medical Writers
PhD's, MD's, Scientists, Researchers
Literature Review Team
Medical Librarian, Clinical Evidence Experts
Project Oversight
Principal Writer / Strategic Leadership
Project Management
Project Management
A Purpose-Built Team for Every Project
Your CER deserves more than just a freelancer. At Criterion Edge, each project is staffed with a dedicated, specialized team to ensure speed, consistency, and subject-matter accuracy.
Global Network of Experts
We tap into a distributed team with deep therapeutic and regulatory experience - working around the clock to move your project forward.
Specialized Roles, Unified Execution
You'll work with protocol developers, medical writers, and therapeutic-area experts aligned to your specific evidence needs.
Scalable, Flexible Staffing
Need to move faster or adjust scope? We scale resources up or down to meet your timeline and budget - without sacrificing quality.
Why Clients Choose Criterion Edge
We don't just check boxes - we partner with your team to deliver high-quality, submission-ready results. Here's what sets us apart:
Experience
Our team includes seasoned experts across regulatory, clinical, and therapeutic domains.
Quality
Built-in quality control ensures every deliverable is compliant, consistent, and audit-ready.
Efficiency
Streamlined workflows and dedicated project teams reduce turnaround time - without cutting corners.
What our clients have to say
Survey Responses
Below are the average scores (out of 5) for each of the criteria we ask our clients to grade us on after every project.
PAST AND UPCOMING WEBINARS
Turn Scientific Information into Organization-Wide Insights with AI
Maximizing the Value of Literature Reviews in Pharma, From Competitive Intelligence to Market Success
Leveraging AI in Regulatory Writing — Opportunities, Oversight & What Medical Device Leaders Need to Know
HOT OFF THE PRESS
Why Leading MedTech & Pharma Teams Turn to Criterion Edge
Pharmaceutical and medical device companies face growing pressure to deliver high-quality, compliant evidence on tight timelines - with limited internal resources. Criterion Edge was built to fill that gap with expert-led, scalable CER services.
Meeting EU MDR Standards With Confidence
From MEDDEV 2.7/1 Rev.4 compliance to Annex XIV requirements and evolving Notified Body expectations, CER requirements demand expertise and vigilance. We navigate the pathway to CE marking for you.
Demanding Reliability from Partners
Late reports, misaligned expectations, or unclear deliverables waste valuable time. Our team is known for quality, clarity, and on-time delivery.
Working Within Tight Budgets
nternal CER teams can be costly and hard to scale. Outsourcing with us helps you meet your clinical evidence goals while staying within budget.
Bridging the Talent Gap
CER expertise is niche and hard to hire. Our experienced writers and reviewers are ready to support your projects right now.
Meet Our Founder: Laurie Mitchell, CEO
With over two decades in the pharmaceutical and medical device sectors, Laurie Mitchell saw firsthand how regulatory and clinical teams struggled with evidence synthesis. She launched Criterion Edge to deliver high-quality CERs that close the gap between complex scientific literature and actionable submission-ready reports.
Under her leadership, Criterion Edge has supported top global brands across regulatory submissions, clinical strategy, and market access for providing expert-written, fully documented CER’s trusted by teams around the world.
Ready to Streamline Your CER Process?
Let’s discuss your Clinical Evaluation Report needs and how Criterion Edge can support your strategic objectives.”