Clinical Evaluation Report (CER) of Class IIb Phototherapy System per EU MDR
A global leader in the Medical industry.
Project Scope
- Create equivalence table with critical technical/design specification
- Address all applicable GSPRs with a GSPR matrix
- In detail clinical data analysis with more than 7 parameters
- A rigorous review of a PMCF plan and report
Project Deliverables
- CEP (Clinical Evaluation Report)
- CER (Clinical Evaluation Plan)
- Equivalent device table
- Searches for both S&P and SOA
- Vigilance data searches
- Complain data
Key Tools
- SARACA’s proprietary AiSummary™ Tool.
- Microsoft word and excel
- PubMed, Embase, Google Scholar
