Clinical Evaluation Report (CER)
Compliance Specialist
Global Regulatory Services
What We Offer
Clinical Evaluation Report (CER) Development & Review
We prepare and review Clinical Evaluation Reports to demonstrate the safety and performance of medical devices in accordance with EU MDR (2017/745) / IVDR (2017/746) requirements. Our structured, evidence-based approach supports regulatory approvals and audit readiness.
CER Documentation
Clinical Evidence
- MDR/IVDR-Compliant CER Preparation Clinical evaluation planning, literature review, data analysis, and report authoring
- CER Review & Regulatory Readiness Gap assessment, updates, and Notified Body–ready documentation support
We provide comprehensive Clinical Evaluation Report (CER) services in line with EU MDR (2017/745) and MEDDEV 2.7/1 Rev. 4 requirements, ensuring your medical device meets regulatory expectations for safety and performance.
Deliverables to the Client
Deliverables
Systematic Literature Search Protocol & Results
Development of a documented literature search strategy using approved databases and keywords.
Critical Appraisal of Clinical Data
Systematic assessment of clinical data for relevance, quality, and scientific validity.
Risk-Benefit Analysis Report
Assessment of identified risks against demonstrated clinical benefits of the device.
Comprehensive Clinical Evaluation Report (CER)
Compilation of a complete, MDR-compliant CER integrating clinical data, appraisal, and conclusions.
Update Strategy for PMS & PMCF
Defines triggers and frequency for CER updates based on post-market data.
Benefits
Regulatory Compliance
Meet EU MDR and MEDDEV requirements for CE marking.
Market Access
Enable smooth notified body review and faster approvals.
Risk Mitigation
Avoid non-compliance penalties and delays.
Evidence-Based Assurance
Demonstrate device safety and performance with robust clinical data.
Lifecycle Support
Keep CER updated with PMS and PMCF data for continued compliance.
Benefits for Your Organization
Call To Action
Simplify Compliance. Accelerate Market Access.
Our global team supports medical device and IVD manufacturers with end-to-end regulatory, quality, and clinical services-ensuring safe, effective, and compliant products at every stage.
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