Clinical Evaluation Reports (CER) for IVD Devices

Artixio provides MDR compliant, comprehensive clinical evaluation of medical devices by seasoned medical devices clinical experts. Our clinical evaluation of medical devices comprises CERs, CEPs, literature review (Medline, Embase) and data synthesis by medical professionals.

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CERs Under MDR/IVDR for Medical Devices and Diagnostics

The EU regulation 2017/745 (MDR) requires all medical devices manufacturers to evaluate clinical data to assess conformity with all medical devices and ensure safety of using medical devices. The guideline also requires manufacturers to update the clinical evaluation report based on the post approval market surveillance.

Artixio offers CER services for IVD medical devices, supporting clinical data analysis, regulatory documentation, and IVDR compliance requirements.

The clinical evaluation process includes,

Learn More about Clinical Evaluation Reports

Learn about EU MDR Guidelines

Artixio's Experience with Notified Bodies

Flexible Models

Literature Search

EU MDR Compliance Literature Search Process

Comprehensive, Global Literature Search using multiple

Timely, fixed price business model

Matured search strategy

Industry recognized Writers and Clinical Evaluators/Medical

Two eye/ peer reviewed report

Clinical Evaluation Reports

EU MDR Compliant Clinical Evaluation

Standardized or customized templates

Well defined SOPs and KPIs

Literature search

Clinical Evaluators and Medical Writers recognized by Notified Bodies

Fixed price model

Right First Time (RFT)

Our medical writers have decades of experience in developing a sound literature search strategy for CERs
Combined with comprehensive clinical evaluation report authoring capabilities, our team continues to deliver high quality CERs with 100% success rate
Our team can work seamlessly with your in house team to capture the product specific insights