Transition of CER for Wound Healing Device from MDD to MDR
A global leader in the Medical industry.
Project Scope
- A lot of articles returned from literature searches
- Developed new appraisal criteria to include the most relevant articles
- Including approx. 30 articles and written summaries for all of them
- In detail, clinical data analysis for all the summary and incorporated to CER
- Developed a claim matrix with all their clinical and technical claims and endpoints
Project Deliverables
- CEP (Clinical Evaluation Plan)
- CER (Clinical Evaluation Report)
- Equivalent device table
- Searches for both S&P and SOA
- Vigilance data searches
- Complaint data
Key Tools
- SARACA’s proprietary AiSummary™ Tool.
- Microsoft word and excel
- Cochrane, Embase
