Clinical Evaluation Reports
Clinical Evaluation Reports
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.
Clinical Evaluation Reports (CER) for Medical Devices and IVD
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.​
Expert Literature Reviewes
Senior Medical Professionals
Notified Body Support
Accurate, Timely & Cost Effective
Experienced Medical Writers
Flexible Models
Literature Search
EU MDR Compliance Literature Search Process
Matured search strategy
Comprehensive, Global Literature Search using multiple databases
Industry recognized Writers and Clinical Evaluators/Medical Practitioners
Timely, fixed price business model
Two eye/ peer reviewed report
Clinical Evaluation Reports
EU MDR Compliant Clinical Evaluation
Literature search
Standardized or customized templates
Clinical Evaluators and Medical Writers recognized by Notified Bodies
Well defined SOPs and KPIs
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
Validated Search Results
Peer Reviewed by Seasoned Clinical and Regulatory Experts
On time submissions for planned time to market
