Artixio

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.

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.

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)

Validated Search Results
Peer Reviewed by Seasoned Clinical and Regulatory Experts
On time submissions for planned time to market

Still Have Questions ?

Get expert answers tailored to your needs.

Specialized Registration
Services Across Multiple Industries

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Expert Regulatory Services To Streamline Compliance

Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review

Regulatory Affairs Across Multiple Countries

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

European

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea

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