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Medical Writing

Clinical and Post-Marketing Safety Reports, CE Marking Techincal Files for the Most Demanding Regulations

ClinChoice’s in-house team of medical writers has diverse experience and proven competency in preparing high-quality reports critical to the progression of clinical trials and ongoing risk evaluation of marketed products. Our understanding of the MEDDEV 2.7/1 Rev 4, MDR 2017/745, and IVDR 2017/746 regulations, GCP guidelines, and relevant ISO standards is key to authoring highly accomplished reports.

Our medical and technical writers contribute to the monitoring and analysis of medical devices across their lifecycle for continuous risk-benefit evaluation.

 

Clinical Phase

  • Clinical Investigation Plan
  • Clinical Evaluation Plan
  • Systematic Literature Review Protocol and Report
  • Investigator Brochure (IB) Development
  • IFUs
  • Clinical Investigation Report
  • Clinical Evaluation Reports
  • Summary of Safety and Clinical Performance (SSCPs)
  • Risk-Benefit Assessment
  • State-of-the-Art

Post-Marketing Phase

  • Post Marketing Surveillance (PMS) Plan
  • Post Market Clinical Follow Up (PMCF) plan
  • Post Market Clinical Follow Up
  • PMS Report
  • PSURs
  • IFUs
  • Trend Reports

Our authors are supported by a literature monitoring team that performs global and local searches to identify relevant information for summaries, reports, and other manuscripts.