Clinical Evaluation Reports 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.
Services We Offer
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.
Artixio offers CER services for IVD medical devices, supporting clinical data analysis, regulatory documentation, and IVDR compliance requirements.
- Expert Literature Reviewes
- Senior Medical Professionals
- Notified Body Support
- Accurate, Timely & Cost Effective
- Experienced Medical Writers
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
Clinical Evaluation Reports
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
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