Medical Devices & Diagnostics
ClinChoice’s in-house medical writers have diverse experience and proven competency in preparing high-quality reports critical to clinical trial progression. ClinChoice’s ISO 13485 certification is a testimony to our medical writing staff’s knowledge of the quality standards necessary for medical devices. Our understanding of the US FDA clinical investigation regulations, MDR 2017/745 and IVDR 2017/746 regulations, GCP guidelines, and relevant international standards is key to authoring highly accomplished reports.
Clinical Development Services
Our medical and technical writers contribute to the monitoring and analysis of medical devices and IVDs throughout the entire product lifecycle.
- Clinical Investigation Plan (CIP)
- Clinical investigation report (CIR)
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Investigator Brochure (IB) development
- Instructions for Use (IFU)
- Risk-benefit Assessment
- IDE Submissions
- Performance Evaluation Plans (PEP)
- Performance Evaluation Reports (PER)
Literature Monitoring
ClinChoice’s literature search specialists apply industry best practices to perform global and local searches that identify precise and complete safety and performance information from a comprehensive array of literature sources for incident reporting, technical and medical writing, and trend reporting. We provide end-to-end services for Systematic Literature Review:
- Search strategy creation
- Inclusion and exclusion criteria development
- Shortlisted article management
- Local and global literature monitoring
- Analytical summary writing
- Literature protocol and reporting