Medical Devices & Diagnostics

ClinChoice’s in-house medical writers have diverse experience and proven competency in preparing high-quality reports critical to post-marketing requirements. Our ISO 13485 certification ensures the medical devices we work with consistently meet regulatory requirements and customer expectations for quality and safety. 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.

Post-Marketing Services

Our medical writers contribute to the monitoring and analysis of medical devices in the post-approval landscape for continuous risk-benefit evaluation.

  • Post-Marketing Surveillance (PMS) plans and reports
  • Post-Market Clinical Follow-Up (PMCF) plans and reports
  • Periodic Safety Update Reports (PSUR)
  • Claims review and copy approval
  • Clinical evaluation plan and reports
  • Systematic literature review
  • Scientific research evaluation
  • Health Economics and Market Access (HEMA)
  • Health Technology Assessment (HTA)
  • Summary of Safety and Clinical Performance (SSCP)

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