Clinical Evaluation Report (CER) of Class III Anesthetics System per EU MDR
A global leader in the Medical industry.
Project Scope
- Preparing system-specific SKUs list from a large list of device components
- Referring more than 50 IFUs for various configuration/components/accessories of the device system
- Large no. of common devices with another system and different classes
Project Deliverables
- Exhaustive CEP and CER template per EU MDR developed by SARACA
- CEP (Clinical Evaluation Plan)
- CER (Clinical Evaluation Report)
- Equivalence establishment Report
- PMS summary with all relevant data
- Clinical claim matrix and addressed all GSPRs
- Analysis and appraisal of clinical data for effective Clinical evaluation
Key Tools
- SARACA’s proprietary AiSummary™ Tool.
- Microsoft word and excel
- PubMed, Google Scholar
