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.
Medical Devices & Diagnostics
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)