Clinical Evaluation Reports
Clinical Evaluation Reports (CER) for Medical Devices and IVD
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.
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.
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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
Clinical Evaluation Reports (CER)
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EU MDR Compliance Literature Search Process
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Comprehensive, Global Literature Search using multiple databases
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Matured search strategy
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Industry recognized Writers and Clinical Evaluators/Medical Practitioners
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Timely, fixed price business model
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Two eye/ peer reviewed report
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EU MDR Compliant Clinical Evaluation
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Standardized or customized templates
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Well defined SOPs and KPIs
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Literature search
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Clinical Evaluators and Medical Writers recognized by Notified Bodies
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Fixed price model
Right First Time (RFT)
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Our medical writers have decades of experience in developing a sound literature search strategy for CERs
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Combined with comprehensive clinical evaluation report authoring capabilities, our team continues to deliver high quality CERs with 100% success rate
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Our team can work seamlessly with your in house team to capture the product specific insights
Validated Search Results
Peer Reviewed by Seasoned Clinical and Regulatory Experts
On time submissions for planned time to market