Our medical and technical writers contribute to the monitoring and analysis of medical devices across their lifecycle for continuous risk-benefit evaluation.
- Clinical Investigation Plan (CIP)
- Clinical Evaluation Plan (CEP)
- Systematic Literature Review Protocol and Report
- Investigator Brochure (IB) Development
- Instructions for Use (IFU)
- Clinical Investigation Report
- Clinical Evaluation Report (CER)
- Summary of Safety and Clinical Performance (SSCPs)
- Risk-Benefit Assessment
- Post Marketing Surveillance (PMS) Plan
- Post Market Clinical Follow Up (PMCF) Plan
- Post Market Clinical Follow Up
- PMS Report
- Trend Reports
Our authors are supported by a medical device literature monitoring team that performs global and local searches to identify relevant information for summaries, reports, and other manuscripts.