Medical Device Regulatory Writing
Criterion Edge specializes in the development and writing of Clinical Evaluation Reports for Class I, II and III Medical Devices
Our experienced regulatory writers partner with your internal cross-functional experts to produce a CER that:
- Presents an in-depth clinical data analysis taken from clinical investigations and literature search results
- Summarizes the State of the Art background and maturity of current technology for your device
- Establishes a strong Equivalence argument (if needed)
- Provides clear summaries of Post Market Surveillance data and Risk-Benefit analysis
Medical Information Specialists will design a comprehensive literature search protocol, with complete documentation of the literature screening and data extraction process. QC reviewers ensure the document is scientifically sound, accurate and adheres to current guidelines and your internal structure. Ask about our fully-developed CER template or we can follow your internal report template.