Expertise to Fit Your Specific Project Needs

Whether your aim is to obtain a CE Mark on your device or progress in your Medical Device Regulation (MDR) compliance journey, developing and maintaining compliant and standardized Clinical Evaluation Reports (CERs) is a critical component of any organization’s day-to-day operations. However, with consistent regulatory changes and shifting priorities, this involved, time-consuming process may not always be top of mind. That’s where Oxford comes in. Our CER solutions can be tailored to fit your needs, and our CER lifecycle-focused approach ensures you will come away with processes in place to update and maintain your CERs for years to come.

Comprehensive CER Experience

• Subject Matter Experts
• Literature Reviewers
• Project Managers
• Medical Writers
• Technical Writers
• QC Specialists

Areas of Service

• Risk Mitigation
• State of the Art Literature Search
• Update of CERs
• Protocol Development
• Regulatory Compliant CERs
• Utilization of Industry Best Practices
• Standardized Process and Quality Control
• Summary of Safety and Clinical Performance (SSCP)
• Program Management to Successful Completion and Turn-Over

Systems & Software

• End Note™
• Distiller™
• SharePoint™
• Literature Search Databases: PubMed™, EMBASE™, and more