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.
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.
- Expert Literature Reviewes
- Senior Medical Professionals
- Notified Body Support
- Accurate, Timely & Cost Effective
- Experienced Medical Writers
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
Validated Search Results
Peer Reviewed by Seasoned Clinical and Regulatory Experts
On time submissions for planned time to market
Still Have Questions ?
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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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