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
Supporting the Following Solutions
- Clinical Evaluation Report Lifecycle
- Final Planning
- Writing
- Quality Control
- Completion Approval