BiTrial CRO | Medical Device Studies
- Risk classification of the device
- Strategy planning for regulatory compliance
- Planning of preclinical conformity and clinical evaluation
- Biological Evaluation Plan and Report compilation
- Performing the preclinical tests:
- Biocompatibility testing
- Safety testing
- Usability testing
- Cybersecurity testing
- Clinical Investigation planning
- Compilation of all Essential Documents
- Conducting Feasibility studies
- Obtaining Clinical Investigation Regulatory approvals
- Conducting the clinical studies
- Preparation of technical documentation
- Implementation of a Quality Management System
- Compilation of the Clinical Evaluation Report
- Support of the full CE marking process
- Guidance for communication and cooperation with the Notified Bodies, and Competent Authorities
- Planning of PMS activities appropriate to the risk classification of the device
- Conducting proactive PMS, such as periodic literature review, vigilance database monitoring etc.
- Planning and conducting PMCF studies
- Reporting of PMS activities, in PMSRs, PSURs, PMCFRs, and trend reports when necessary