Our Experienece
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Clinical Evaluation Report (CER) of Spine Implant per TGA
- Understanding of various the surgical procedures
- Consideration of equivalence devices per MDR requirement
- Drafting the details of the compatibility of accessories and complex instruments with the implants
- CEP (Clinical Evaluation Plan)
- CER (Clinical Evaluation Report)
- Equivalent device table
- Searches for both S&P and SOA
- Vigilance data search
- Complaint data
- SARACA’s proprietary AiSummary™ Tool
- Microsoft word and excel
- PubMed, Google Scholar, Embase
Case Studies
We have provided a few projects which we have executd for our customers. Please reach out to us for more details