Clinical Evaluation Report (CER) of Spine Implant per TGA
A global leader in the Medical industry.
Project Scope
- 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
Project Deliverables
- CEP (Clinical Evaluation Plan)
- CER (Clinical Evaluation Report)
- Equivalent device table
- Searches for both S&P and SOA
- Vigilance data search
- Complaint data
Key Tools
- SARACA’s proprietary AiSummary™ Tool
- Microsoft word and excel
- PubMed, Google Scholar, Embase
