Our Experienece
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Clinical Evaluation Report (CER) of Class IIb Phototherapy System per EU MDR
- 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
- CEP (Clinical Evaluation Report)
- CER (Clinical Evaluation Plan)
- Equivalent device table
- Searches for both S&P and SOA
- Vigilance data searches
- Complain data
- SARACA’s proprietary AiSummary™ Tool.
- Microsoft word and excel
- PubMed, Embase, Google Scholar
Case Studies
We have provided a few projects which we have executd for our customers. Please reach out to us for more details