Clinical Safety Management – Scoping, review and report
We offer our Clinical Safety Management service to review your progress in creating a compliant clinical risk management process and producing and maintaining the necessary documentation (Clinical Safety Case, Safety Case Report, Hazard and Incident Logs). We deliver a comprehensive report to support your team in identifying your progress to compliance. Depending on the progress you have made to date, we can either act as your named Clinical Safety Officer or support your team on the journey to compliance.
To progress this work, we expect to:
- Hold discussions with relevant personnel (development, product, customer success, support) to understand your current business processes and product lifecycle.
- Creation of documented clinical risk management process that aligns with this.
- Establish your multidisciplinary team clinical risk management team and walk through the risk management process with them
- Work with you to create the initial set of DCB0129 mandatory documents:
- Clinical Safety Case Report
- Hazard Log
- Clinical Risk Management Plan
- Clinical Incident Log